Pentax EG-290Kp, EC-380LKp Owner's Manual

PENTAX VIDEO GI SCOPES

EG-290Kp

OWNER’S MANUAL

EC-380LKp

Intended Use (Gastroscope)

These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum and Small Bowel.

The instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Never use the endoscope for any purpose other than that for which it has been designed.

The video endoscopes contained in this manual can only be used with PENTAX video processor, model EPK-1000 and EPK-i.

Intended Use (Colonoscopes)

These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Lower Gastrointestinal Tract. The This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum.

These instruments are introduced via the rectum when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Never use these endoscopes for any purpose other than that for which they have been designed.

These video endoscopes contained in this manual can only be used with PENTAX video processors, model EPK-1000 and EPK-i.

Notes

Read this manual before operating, and save this book for future reference. Failure to read and thoroughly understand the information presented in this manual, 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 manual may result in damage to, and/or malfunction of, the equipment.

This manual describes the recommended procedures for inspecting and preparing the equipment prior to its use and for the reprocessing and maintenance of the equipment 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.

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.

Current infection control guidelines require that G.I.scopes and other semi-critical medical devices, that normally come into contact with intact mucous membranes, such as in the gastrointestinal tract, must at least be high-level disinfected before patient use. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each clinical use. It must be recognized that infection control practices involve many complex and often controversial issues which are constantly evolving. PENTAX strongly recommends that user remain informed of the latest federal and local regulations, and encourages users to follow infection control guidelines developed by various organizations for health care professionals.

The text contained in this manual 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 manual or concerns pertaining to the safety and/or use of this equipment, please contact your local PENTAX representative.

Sterility Statement

The instruments identified in this instructional booklet are reusable medical 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 appropriate cleaning and either highlevel disinfection or sterilization process.

Conventions

Throughout this manual, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided;

: could result in death or serious injury.

: may result in minor or moderate injury or property-damage.

: may result in property-damage. Also, advises owner/operator about important information on the use of this equipment.

Prescription Statement

Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional.

EC REP

Symbol for “MANUFACTURER”

Symbol for “DATE OF MANUFACTURE”

Symbol for “AUTHORISED REPRESENTATIVE”

TABLE OF CONTENTS

1. NOMENCLATURE AND FUNCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1-1. VIDEO ENDOSCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1-2. ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1-3. VIDEO PROCESSOR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2. PREPARATION AND INSPECTION FOR USE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2-1. INSPECTION OF THE VIDEO PROCESSOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2-2. INSPECTION OF ENDOSCOPE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2-3. PREPARATION JUST BEFORE INSERTION OF ENDOSCOPE . . . . . . . . . . . . . . . 13

3. DIRECTIONS FOR USE

3-1. PRETREATMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3-2. INSERTION AND WITHDRAWAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3-3. BIOPSY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3-4. LASER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3-5. ELECTRO-SURGERY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4. CARE AFTER USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4-1. ENDSCOPES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4-1-1 INTERNAL CHANNELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4-1-2 PRE-CLEANING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

4-1-3 CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4-1-4 HIGH-LEVEL DISINFECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4-1-5 STERILIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4-2. ENDOSCOPIC ACCESSORY INSTRUMENT (EAIs) AND ENDOSCOPE

COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4-2-1 CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4-2-2 DISINFECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4-2-3 STERILIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4-3. WATER BOTTLE ASSEMBLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

5. POST REPROCESSING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5-1. SERVICING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5-2. CARE AND MAINTENANCE TIPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

- 1 -

1. NOMENCLATURE AND FUNCTION

1-1. VIDEO ENDOSCOPE

NOTE:

To avoid damaging the endoscope, do NOT twist, rotate or bend excessively any of the rubber strain reliefs.

ENHANCE BUTTON

Push to activate the VCR for recording live procedures.

UP/DOWN DEFLECTION LOCK When this lever is in the “F” position, turned clockwise, the bending section moves freely. When turned counterclockwise, the bending section becomes progressively more stabilized.

UMBILICAL CABLE

RIGHT/LEFT DEFLECTION CONTROL KNOB

RIGHT/LEFT DEFLECTION LOCK Functions similar to Up/Down lock

UP/DOWN DEFLECTION CONTROL KNOB

“F” (FREEZE) BUTTON Push to freeze an image.

“C” (COPY) BUTTON Push to activate the hardcopy system that was selected between “FILE” and “HARD COPY”.

MODEL DESIGNATION

SUCTION CONTROL VALVE (OF-B120) Depress to remove fluids or air through the instrument channel.

RUBBER INLET SEAL (OF-B190) Allows passage of accessories while preventing escape of fluids and air.

INSTRUMENT CHANNEL INLET For introduction of biopsy forceps and other accessories

CONTROL BODY

AIR/WATER FEEDING VALVE (OF-B121) Covering of hole in the top of the valve delivers

pressurized air. Covering of the hole and fully depressing the valve delivers pressurized water.

BUTTON

Freeze

VCR

Hardcopy

BUTTON

EPK-1000

Freeze

VCR

Hardcopy

EPK-i

* The function can be changed. For more details, refer to the manual supplied with the processor

RUBBER STRAIN RELIEF

- 2 -

WARNING:

Note:

Immediately after use, the metal light guide prong and the electrical contacts/pins of the endoscope may be HOT. To avoid burns, do not touch these areas immediately after use. For safer handling after a procedure, grasp the PVE connector housing.

Ensure that the soaking cap has been securely attached (by properly rotating it) to prevent the cap from coming off during reprocessing. Failure to securely attach the soaking cap can result in scope damage.

INSERTION TUBE

ELECTRICAL CONTACTS

LIGHT GUIDE Transmits light from light source to distal end of endoscope.

ETO GAS STERILIZATION VENTING CAP OF-C5 Provides venting of endoscope interior to equalize internal and external pressures. This cap must be removed before immersion.

NOTE: See important separate section

regarding the use of this cap!

SUCTION NIPPLE For attachment to external suction source

PVE CONNECTOR Can be rotated within a 180 range

AIR/WATER PORT To connect feeding tube from water bottle assembly.

FEED BACK TERMINAL Certain manufacturers’ electrosurgical units, such as older Olympus models, require the connection of a scope feedback cord (S-cord) to this feedback terminal.

VENTING CONNECTOR Accepts “RED” ETO GAS Sterilization Venting cap. Also accepts Leakage Tester.

PVE SOAKING CAP

OE-C9

BENDING SECTION

RED

This cap must be securely attached before immersion.

DISTAL END (Refer to the inside rear cover of this manual)

RUBBER STRAIN RELIEF

- 3 -

1-2. ACCESSORIES

CAUTION:

• Because of the effect that accessories used through the instrument channel of the endoscope can have on the performance of the endoscope itself, it is strongly recommended that PENTAX accessories be used with PENTAX endocopes. If a unique or highly specialized accessory is available from another source, please contact PENTAX to arrange a test of its compatibility before using it through the PENTAX endoscope.

• Maximum outer diameter of an endoscopic accessory instrument must be at least 0.2 mm less than the specified instrument channel diameter in PENTAX endoscopes. Working length of an endoscopic accessory instrument should be approximately 30 cm longer than the endoscope working length.

NOTE:

• Depending upon country and/or local PENTAX distributor, each PENTAX endoscopic accessory may be an optional accessory.

• For patient contact endoscopic accessories, follow the specific and detailed instructions on use, care and maintenance supplied with each product.

• To confirm the exact condition of any new accessory device, check the labeling/packaging accompanying the product. Each label/package should clearly identify the contents as either sterile or non-sterile.

HANDLE

(CS6021SN)

FLEXIBLE SHAFT

WHITE BRISTLE

1) Cleaning Brush for Instrument Channel

2) Cleaning Brush for A/W Suction Valve Cylinder

( CS-C5S )

3) Biopsy Forceps

ENHANCED FLEXIBLE PORTION

CUPS

FLEXIBLE SHAFT

GRIP

HANDLE

Pink handle defines autoclavable forceps.

- 4 -

1-3. VIDEO PROCESSOR

CAUTION:

Please refer to the instruction supplied with the processor.

NOTE:

Do not use the new PENTAX OS-H4 water bottle cap with the older OS-H2 water container/bottle. Although the cap may appear to fit onto the bottle, air may escape resulting in insufficient pressure and flow of air and water during the endoscopic procedure. Both the PENTAX water bottle cap and bottle (container) are identified by their appropriate model designation. Ensure that an OS-H4 cap is used only with the OS-H4 water container/bottle. Do not overtighten the bottle cap. Overtighting can cause the bottle cap to break.

WARNING: The lifetime of the lamp in EPK-i processor is 500 hours. Prior to use, check the lamp life meter on the rear panel to ensure the lamp life is less than 500 hours. After 500 hours of use, the image quality will deteriorate. Excessive use of the lamp beyond 500 hours could break the lamp inside the equipment resulting in damage to the equipment.

WARNING: The lifetime of the lamp in EPK-i processor is 500 hours. Prior to use, check the lamp life meter on the front panel to ensure the lamp life is less than 500 hours. After 500 hours of use, the image quality will deteriorate. Excessive use of the lamp beyond 500 hours could break the lamp inside the equipment resulting in damage to the equipment.

NOTE:

The lamp life could be affected by frequency of use. In which case, the lamp life might become shorter than its respective rated hours (EPK-i: 500 hours, EPK-1000 and EPK-100p: 400 hours)

WATER BOTTLE

LAMP SWITCH

AIR PUMP SWITCH

LCD

POWER SWITCH

INTERFACE SOCKET

EPK-1000

POWER SWITCH I : ON O: OFF

LAMP SWITCH

INTERFACE

SOCKET

BRIGHTNESS CONTROLS

AIR PUMP SWITCH

WATER BOTTLE

EPK-i

EPK-1000

- 5 -

2. PREPARATION AND INSPECTION FOR USE

Prior to use, the endoscope, video processor and endoscopic accessory instruments must be carefully inspected for cleanliness and proper function to determine that they are appropriate for patient use:

2-1. INSPECTION OF THE VIDEO PROCESSOR

Please refer to the Owner’s Manual of the specific model of PENTAX video processor for complete instructions.

1) Attach water bottle assembly, 2/3 filled with sterile water to the appropriate location on the left side of the video processor.

2) Set the drain lever on the water bottle assembly to the upright position labeled A/W (air/water).

3) Plug the processor into a properly grounded receptacle with the power switch in the OFF position.

4) Make sure that the PENTAX PVE connector is aligned with the interface socket on the front panel of the processor.

5) Connect the endoscope to the interface socket on the processor as illustrated. Rotate the lever of the interface socket clockwise after insertion.

6) Connect the air/water feeding tube from the water bottle assembly to the air/water port on the side of the PVE connector.

7) Turn the processor and air pump to the “ON” position and check for proper functioning.

8) Press the lamp switch of the processor to ignite the lamp.

NOTE:

PENTAX video endoscopes contained in this manual are only compatible with PENTAX video processor, model EPK-1000 and EPK-i.

CAUTION:

To avoid discontinuation of endoscopic procedure, have an extra (spare) instrument available as a standby device. Should any unforeseen event or circumstance render the original instrument inoperable and/or unsafe for patient.

WARNING:

The addition of defoaming agents to the water supply is NOT recommended. Due to their nature, these silicone based agents cling tenaciously to surfaces. Unless they are rinsed very thoroughly, a “barrier” could be created which could reduce the effectiveness of the disinfection/sterilization process. Additionally, repeated use of such defoamers could eventually lead to residual silicone build up resulting in equipment malfunction such as clogged air and/or water channels.

EPK-1000

WATER BOTTLE

air/water feeding tube

CAUTION

Failure to do so may create a “miscommunication” between the scope and processor and may result in the loss of the system’s automatic brightness control and in excessive light emission from the scope. Excessive light intensity can in turn increase the amount of delivered thermal energy causing heating of the scope tip, specifically the illumination (LCB) cover glass and/or objects in contact with the distal cover glass.

- 6 -

9) Prior to each procedure, check the endoscope image quality displayed on the monitor. Confirm that the image quality, color, automatic brightness (iris) functions are acceptable as per the instructions provided with the PENTAX video processor.

2-2. INSPECTION OF ENDOSCOPE

Before proceeding with inspection of individual functions, PENTAX endoscopes should be tested for the integrity of their water-tight design (example: tear in the instrument channel). This test is described in another section of this manual entitled: “Leakage Testing.”

1) Inspection of the Insertion Tube a) Check the entire surface of the insertion tube for abnormal conditions such as dents, crush marks, wrin-

kles, bumps, buckles, excessive bending, protrusions, bite marks, peeling of outer sheath, cuts/holes or other irregularities. Any crush or indentation of the flexible shaft of the endoscopes can cause damage to the internal mechanisms of the endoscopes.

b) Similarly, check the condition of the umbilical cable for outward signs of damage such as buckling, crush

marks, etc.

c) Make sure that the entire endoscope is clean and has been subjected to either a high-level disinfection or

sterilization process before each patient use.

NOTE:

As indicated elsewhere in PENTAX product labeling, endoscopes particularly the quality of the endoscopic image should be checked prior to patient use.

CAUTION:

If the endoscope is intended to be clinically used after testing of individual scope functions (suction, air/ water delivery, water jet, etc.) without further reprocessing, the following precaution should be exercised. Use “fresh” distilled or sterile water during individual scope function tests to avoid recontamination of the previously reprocessed instrument by waterborne microorganisms. Tap water, especially that which may be left idle and uncovered for a prolonged period of time, should not be used during any inspection/testing of the endoscope.

CAUTION:

Various types of endoscope leakage testers exist including manual, electro-mechanical and “automated” versions, some of which are stand alone units and others which may be integrated into Automated Endoscope Reprocessors (AERs)/Washer-Disinfectors (WDs). It must be recognized that PENTAX does not evaluate non-PENTAX leak tester systems to satisfy their specific products claims, for their effectiveness to accurately detect leaks and/or for their compatibility with PENTAX endoscopes. Insufficient pressures may adversely affect the endoscope, especially if pressurization occurs during automated reprocessing at elevated temperatures. PENTAX accepts no responsibility for use of non-PENTAX leakage testers. Users should check with the leakage tester manufacturer and confirm their specific product claims, including compatibility with PENTAX endoscopes at various temperatures and their ability to detect leaks with/without fluid immersion and with/without flexing of the scope’s distal bending section.

CAUTION:

To avoid further damage to the endoscope or the possibility of malfunction during a procedure, do not use an endoscope with any abnormalities or outward signs of damage.

WARNING:

All instruments must be reprocessed prior to first time use, after any repairs/service and before every patient use. When utilizing chemo-thermal processes for reprocessing the endoscope, the instrument should be allowed to return to room temperature prior to use and/or further handling.

- 7 -

NOTE:

• The distal end of the endoscope as well as the electrical contacts/pins on the PVE connector must be protected against damage from impact. Never apply excess force such as twisting, or severe bending to the flexible portion of the endoscope.

• During pre-use inspection, ensure that the distal objective lens and the illumination (LCB) cover glass are clean and no residues are present on these distal surfaces. If not, crisp images can NOT be displayed. Wipe with a gauze or the like moistened with enzymatic detergent solution.

• As indicated elsewhere in PENTAX product labelling, endoscopes particularly the quality of the endoscopic image should be checked prior to patient use.

• Ideally all patients should be prepped well to maximize visualization of the intended areas of interest. Patient material and sections should be removed from the area of observation to eliminate the potential to blur the endoscopic image and/or obscure the illumination system.

• Prior to a procedure, remove debris or secreta from observation area as much as a possible.

• Continuing use of the light guide with sticky debris might cause steam because debris is deprived of moisture by heat. If steam is found on the light guide during a procedure, stop it immediately and withdraw the scope carefully from a patient.

NOTE:

Flexible endoscopes and other sophisticated medical instruments are constructed of special materials, unique parts and intricate components with strict dimensional tolerances. Specialized assembly techniques and application of specific sealants and/or adhesives are required to ensure the watertight integrity and maintain the functionality of these devices. It is therefore imperative that endoscopes be routinely checked to ensure that parts used in their construction are not loose, missing or compromised that could otherwise negatively affect the functionality of these devices. Compromised or loose components could result in device failure, scope damage (via fluid invasion) and/or in incomplete decontamination of used instruments. PENTAX recommends that prior to use endoscopes should be carefully inspected for their integrity and checked for any “looseness” in the mating or joining of components including the following parts/areas:

• the channel inlet assembly (biopsy inlet port) (

① )

• the suction nipple/connector (

② )

• the air/water inlet port (

③ )

• any valve cylinder (

④ )

• basically, any inlet or outlet port associated with an internal channel, an indirect patient contact portion of the endoscope

• rubber strain relief along insertion tube and umbilical cable (rotate clockwise only to tighten)

One method to check for looseness is to lightly grip the exposed part, and while grasping the component carefully attempt to move it in various directions. Use of a lintfree gauze while grasping metal parts is recommended as a protection for one’s fingers.

If any part/component remains loose (after attempting to tighten) and/or if there is any indication or suspicion of an abnormality or outward signs of damage, do NOT use the endoscope. Contact your local PENTAX service facility.









- 8 -

2) Inspection of Deflection Controls and Locks a) Slowly manipulate the Up/Down and the Right/Left

control knobs to see that they function smoothly. Be certain that a full and appropriate range of deflection is possible.

b) Engage the deflection locks to be certain that the

position of the deflected tip can be stabilized.

CAUTION:

To avoid damaging the endoscopes, do NOT twist, rotate or bend excessively any of the rubber strain relief (

①, ②

) during inspection, clinical use, reprocessing or any handling activity. Be particularly cautious for

the insertion tube strain relief (

①

). When wiping the insertion tube and the umbilical cable, use a slow back and forth motion to wipe them along the tube/cable. Never apply excessive force or torque on these strain reliefs or slim tubes/cables. During ANY handling of the instrument avoid excess force, twisting, rotation and/ or bending of the actual insertion tubes and umbilical cables to prevent inadvertent damage (crush, compression, deformity, etc.) to these parts as well as to internal components contained within the endoscope.

Twisting or Rotating

Bending

RIGHT-LEFT

UP-DOWN

NOTE:

The deflection locks are of the friction type and the degree of friction is adjustable. The degree of locking friction depends on the rotational position of the lever.

CAUTION:

ANY lack of smooth operation of the deflection controls may be an early indication of internal damage to and/or part(s) failure within the endoscope’s angulation system. To avoid the possibility of further endoscope damage or the potential for malfunction of the angulation system, do NOT use the endoscope if the angulation mechanism does not operate properly. Prior to use ensure that the deflection controls can rotate smoothly, that there is no grinding or excess friction within the angulation system and that the distal bending section bends freely and smoothly. NEVER APPLY EXCESSIVE FORCE TO THE DEFLECTION CONTROLS! When an endoscope exhibits excessive “knob play” or if angulation is lost in any direction, do NOT use the instrument. Excessive “knob play” can be defined as rotating of the angulation control knob(s) in any one direction for more than 30 degrees without any corresponding distal tip deflection. The examples above are indications that service is required to avoid more serious problems with the angulation control system, including angle or pulley cable/wire breakage and/or the possibility of a “frozen” distal bending section. A “frozen” bending section can make instrument extraction from a patient more difficult.

- 9 -

3) Inspection of Air/Water Feeding a) Prior to use, the air/water feeding valve (OF-B121)

should be inspected. Remove the valve from the control body and make sure that the black rubber check-valve (OE-C14) in good condition is properly attached to the bottom of the metal valve stem.

b) If the rubber check-valve is missing or not attached

properly, correctly reposition the check-valve by turning it several times on the air/water valve stem. For proper positioning, there should be no clearance (gap) between the rubber check valve and the metal air/water valve stem

c) To confirm that the check-valve is attached properly, visually inspect the check-valve and install the air/

water valve into the air/water cylinder on the control body. Proceed to test the air delivery function.

d) Connect the scope to the video processor. Turn air pump “ON” to desired pressure setting.

Place the scope distal tip into sterile water and confirm that no air bubbles exit the distal air nozzle.

e) To inspect air delivery, cover the hole at the top of

the air/water valve and confirm that air flows freely from the air/water nozzle at the scope disital tip.

f) By depressing the air/water feeding valve, the water

delivery system is activated. Water should flow in a steady stream from the air/water nozzle at the distal tip of the endoscope. (This may take several seconds on the initial attempt.) USE STERILE

WATER ONLY.

WARNING:

A worn or damaged check-valve should be replaced with a new one which has already been subjected to a high-level disinfection or sterilization procedure (Check valve set, model OE-C15 is optionally available). For repeated use, always ensure that the check-valve has already been reprocessed. A damaged, worn or missing check-valve could create continous air flow or excessive air insufflation and result in potential patient injury such as pneumatic perforation. If the check-valve is not attached properly, it could fall off during the endoscopic procedure and result in potential injury to the patient.

CAUTION:

If there is any doubt as to the suitability for use of the rubber check-valve, replace with a fully reprocessed one prior to each procedure. A set of 10 pieces of the OE-C14 check-valve are available in a package as model OE-C15.

WARNING:

If air bubbles are observed during the test, the rubber check-valve MUST BE REPLACED. Repeat the test procedure with a new check-valve (OE-C14).

OF-B121

OE-C14

Don’t let the skirt fold under

Action

Result

Air Feeding

Water Feeding

–

- 10 -

g) Release the air/water valve to determine if the valve

freely returns to its OFF (neutral) position and delivery of water (and air) ceases.

h) If the air/water valve OF-B121 does not function

properly, does not move smoothly or feels “sticky”, remove the valve and apply a very small amount of silicone oil lubricant onto all the O-rings. Do NOT use excess oil, avoid “blobs”, large drops and/or squirts of oil directly onto the metal valve stems instead, simply place a small droplet of oil on one’s sterile gloved forefinger and gently swirl between thumb and forefinger. Next place the valve with

O-ring in-between thumb and finger and gently rotate the valve so that the oil is evenly applied to the outer edges of each rubber O-ring. Make sure the oil is applied to all O-rings and wipe off all excess. Do NOT apply excess oil. Doing so can allow for inadvertent migration of the oil inside channels or other areas not intended to be lubricated.

i) If air and/or water do not flow properly, NEVER attempt to clear the air or water nozzles with a needle or

any other sharp object. Instead, the following steps should be followed.

1 Disconnect the endoscope from the video processor. 2 Remove the air/water feeding valve. 3 Using a cotton tipped applicator and alcohol, clean the valve recess (receptacle) in the control body thor-

oughly to remove any debris. Do NOT attempt to insert the applicator into the small openings within the valve receptacle as the cotton or applicator could become lodged within these openings and cause channel blockage.

4 • Following the section of this manual for cleaning the air and water channel with detergent, flush deter-

gent through both the air and water channel. Then flush the air several times to force any residual solution out of the channel.

• Remove the adapters and install the air/water feeding valve.

(Alternate) By leaving the air/water valve in the cylinder instead of the adapter, one may direct pressured fluid (or air) independently to either channel to expel debris from and/or more forcefully flush solution into either the air or water channel. This should not be attempted on a completely clogged/blocked air or water channel/nozzle.

5 Test for normal delivery of air and water. It may be necessary to repeat the above procedure if normal air

and water delivery is still not available.

OF-B121

O Ring : OF-B143

NOTE:

Excessive silicone oil (lubricant) should be avoided to prevent occlusion of the internal air or water channels/nozzles and potential impairment of the normally clear endoscopic image.

NOTE:

If blockage of the line is encountered, avoid use of excessive pressure to prevent scope damage.

NOTE:

Do NOT apply excessive force in an attempt to unblock a clogged channel as the channel and/or brush could become damaged. Whenever channel damage is suspected, the endoscope should be leak tested. If repeated attempts to flush the air/water system are unsuccessful, do not attempt to use the endoscope on a patient. Contact the PENTAX service department.

NOTE:

Prior to clinical use, it is important that the entire air channel system be dry. Failure to thoroughly dry the air system could result in an unclear or blurry image caused by very fine droplets of moisture being swept over and/or onto the objective lens at the distal end of the scope.

- 11 -

4) Inspection of Suction Mechanism a) Prior to use suction control valve (OF-B120)

should be inspected. Remove the value from the control body and make sure that the rubber portion is not damaged or worn.

b) Position the valve OF-B120 so that the small metal

tab near the base on the valve stem aligns with the notched suction valve cylinder, also color coded in orange. Install the valve into the suction cylinder by gently pushing the valve into the cylinder. Never apply excessive force to push the valve into the suction cylinder.

c) Connect suction tubing from an external suction

source to the suction nipple located on the PVE Connector at the end of the umbilical cable. Place the distal tip of the endoscope in a basin of sterile water and depress the suction control valve. Water should be rapidly aspirated into the suction system collection container.

CAUTION:

The instrument, Air/Water channel systems are made of stainless steel, poly phenylene oxide and fluorine-contained polymers. When any fluids are used with this scope, please read carefully and follow all instructions in the manual supplied with the fluids for use and pay special attention to any reactions with the materials identified in the intended fluid path. Only the user can determine if the fluids are appropriate for patient use.

Silicone oil

O-Ring OF-B127

OF-B120

Incorrect

Correct

metal

OF-B120

WARNING:

Improperly installed valves may not function as originally intended. Such valves may not return to their neutral (released) positions and/or they may provide continuous suction. Continuous aspiration can cause loss of air/fluid, difficulty in maintaining proper insufflation and/or inadvertent suctioning of tissue into the distal instrument channel opening.

WARNING:

A worn or damaged value and/or O-ring should be replaced with a new one. The entire value mechanism should be subjected to a high-level disinfection or sterilization procedure prior to use (O-ring set, model OF-B127, is optionally available). Failure to do so could result in continuous aspiration which in certain clinical situation can suction tissue into the distal channel opening at the scope tip and/or create a loss of insufflated air via the suction system. A compromised valve could also result in the potential for reflux or spit-back of patient fluids that may present infection control risks.

SUCTION TUBE

DEPRESS

SUCTION NIPPLE

- 12 -

d) Release the suction control valve to determine if the valve freely returns to its OFF position and the aspira-

tion of water ceases.

e) If the suction valve does not move smoothly or feels “sticky”, remove the valve from the suction cylinder

on the control body of the endoscope. Apply a small amount of silicone oil lubricant, OF-Z11, onto rubber part and rubber the O-ring. Place a small droplet of oil on one’s sterile gloved forefinger and gently swirl between thumb and forefinger. Next place the valve with O-ring in-between thumb and finger and gently rotate the valve so that the oil is evenly applied to the outer edges of the rubber O-ring. Remove/wipe off excess lubricant with a soft gauze. Do not use excessive silicone oil.

5) Inspection of Biopsy Forceps and Instrument Channel a) Make sure there are no kinks in the flexible shaft of

the biopsy forceps.

b) The jaws of the forceps must be free of any residual

debris. Any debris must be cleaned from the forceps before they are used. Use only sterile forceps.

c) The handle mechanism on the forceps should be

operated to open and close the jaws. This mechanism should operate freely.

d) Close and inspect the jaws of the forceps to make

sure the cups are in proper alignment. If the forceps has a spike, the spike must be completely straight and fully within the cups.

e) Any accessory should be slowly inserted through the instrument channel inlet with the endoscope in a

straight position. There should be no resistance encountered. If resistance is encountered, do not attempt to introduce the accessory further. The instrument channel may be damaged and the endoscope should not be used. Contact the PENTAX service department.

CAUTION:

If the instrument is to be used immediately after the inspection, use only “fresh” distilled or sterile water. To avoid recontamination of a previously reprocessed endoscope, avoid use of idle/uncovered tap water.

NOTE:

A rubber inlet seal in good condition must be on the instrument channel inlet to prevent the loss of suction and a risk of cross contamination to the end user due to the potential for reflux (spit-back) of patient fluids. Worn seal will result in leakage and should be replaced. To ensure maximum performance of these sealing mechanisms, consider replacing the rubber inlet seal with a new fully reprocessed one for each procedure.

WARNING:

The use of any forceps or accessory that shows any sign of damage or difficulty of operation must be avoided. Any malfunction of a forceps or accessory during a patient procedure could result in serious injury to the patient. Also, the use of damaged forceps or accessories may result in serious and costly damage to the endoscope.

WARNING:

All patient contact accessories must be thoroughly cleaned and subjected to an appropriate high-level disinfection or sterilization process before being used for the first time and subsequently after each clinical use.

CAUTION:

OPEN

- 13 -

2-3. PREPARATION JUST BEFORE INSERTION OF ENDOSCOPE

1) If the endoscope has just recently been reprocessed, has been prepared or stored properly and passed all preprocedure inspections, the instrument should be ready to use. If necessary, the scope’s insertion tube may be wiped down with a gauze dampehed with 70-90% ethyl or isopropyl alcohol.

2) Gently wipe the insertion tube with a gauze moistened with 70-90% ethyl or isopropyl alcohol.

3) Gently clean the objective lens with a cotton-tip applicator moistened with 70-90% ethyl or isopropyl alcohol. A lens cleaner (anti-fogging agent) may also be applied via gauze or other applicator.

4) Check the endoscopic image and confirm that it is of acceptable quality for clinical use. Refer also to the owner’s manual supplied with the PENTAX video processor for inspection of the image quality.

5) (SCOPES TO BE INTRODUCED TRANSORALLY) Prior to trans-oral insertion of the endoscope, place a bite-block (mouthpiece) into the patient’s mouth to protect the endoscope from damage during the procedure. Failure to do so can result in scratches, tears and/or crushing of the insertion portion of the endoscope.

6) Apply a medical grade water soluble lubricant to the insertion tube. Do not use petroleum based lubricants.

NOTE:

Accessories should always be inspected and checked with the particular endoscope prior to each procedure.

WARNING:

Do NOT clinically use the endoscope if any irregularity or abnormality is suspected. If there is any doubt as to the suitability of use for any endoscope component, replace it with a new fully reprocessed one. An instrument irregularity may cause scope damage and/or compromise patient or user safety.

WARNING:

Every endoscope should be properly disinfected or sterilized before being used for the first time. The endoscope should have been properly cleaned, disinfected or sterilized after any previous use and after being returned for any repairs/service. Refer to the companion manual describing in detail PENTAX reprocessing instructions.

WARNING:

Current infection control guidelines require that endoscopes and their patient contact accessories either be sterilized or at the least be subjected to high-level disinfection. Accessories which ENTER STERILE TISSUE or THE VASCULAR SYSTEM must be sterilized before patient use. It is recommended that any accessory intended for use in the biliary tract be subjected to an appropriate sterilization process. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each clinical use.

NOTE:

Contact the manufacturer and follow local regulations regarding safe use, appropriate handling and disposal of alcohol products. Material Safety Data Sheets (Health and Safety Data Sheets or similar documents depending upon country) available from the alcohol manufacturer should provide guidance to end users about composition, hazards, chemical and physical properties, first aid, handling and storage, stability, precautions, disposal, etc. associated with alcohol solution.

+ 36 hidden pages

Pentax EG-290Kp, EC-380LKp Owner's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual