FG-UX Series Owners Manual Jan 2011

IMPORTANT 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.

Intended Use The Ultrasound Fiberscope is intended to provide endoscopic optical and sonographic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

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 high-level 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.

CAUTION

:

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

NOTE

:

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

WARNING

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 to the patient and/or user. Furthermore, failure to follow the instructions in this manual may result in damage to, and/or malfunction of, this equipment. 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. PENTAX ultrasound endoscopes can only be used with Hitachi Medical Corporation manufactured ultrasound systems. 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. This manual describes the recommended procedures for inspecting and preparing the equipment prior to its use and for the cleaning 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 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 gastroscopes 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 clinical 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.

ULTRASOUND GI FIBERSCOPE

TABLE OF CONTENTS 1.

NOMENCLATURE AND FUNCTION... 1-1. ULTRASOUND UPPER G.I. FIBERSCOPE... 1-2. ACCESSORIES... 1-3. LIGHT SOURCE...

2 2 4 5

2.

PREPARATION AND INSPECTION FOR USE... 2-1. INSPECTION OF LIGHT SOURCE... 2-2. INSPECTION OF FIBERSCOPE... 2-3. PREPARATION OF ULTRASOUND SCANNING UNIT... 2-4. PREPARATION BEFORE THE EXAMINATION... 2-5. PRAPARATION JUST BEFORE INSERTION OF FIBERSCOPE...

6 6 8 16 17 20

3.

DIRECTIONS FOR USE... 21 3-1. PRETREATMENT... 21 3-2. INSERTION AND WITHDRAWAL... 21 3-3. BIOPSY... 24 3-4. PRECISE ACCESSORY CONTROL (FG-36UX ONLY)... 25

4.

CARE AFTER USE... 26 4-1. CARE AFTER EACH PROCEDURE... 26 4-1-1 PRE-CLEANING AT THE EXAMINATION ROOM... 26 4-1-2 CLEANING AT THE WORK ROOM... 27 4-1-3 CLEANING OF ACCESSORIES... 31 4-1-4 INTERNAL SCHEMATICS OF ENDOSCOPES... 32 4-1-5 HIGH-LEVEL DISINFECTION... 35 4-1-6 DISINFECTION OF ACCESSORIES... 39 4-1-7 STERILIZATION AND AERATION... 40 4-1-8 STERILIZATION OF ACCESSORIES... 42 4-2. POST REPROCESSING... 43 4-3. SERVICING... 43 4-4. CARE AND STORAGE OF PENTAX WATER BOTTLE ASSEMBLY MODEL OS-H2 AND OS-H4... 44 4-5. CARE AND MAINTENANCE TIPS... 46 LEAKAGE TESTER INSTRUCTIONS... SPECIFICATIONS

48

1. NOMENCLATURE AND FUNCTION 1-1. ULTRASOUND UPPER G.I. FIBERSCOPE

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.

MODEL DESIGNATION

130˚ UP

SUCTION CONTROL VALVE (Part # OF-B68): Depress to remove fluids or air through the instrument channel.

120˚ LEFT 130˚ DOWN

AIR/WATER/BALLOON FEEDING VALVE (Part # OF-B123): 120˚ RIGHT Multi-Function 3 stage Valve - Covering of hole delivers pressurized air for insufflation - Covering of hole and pressing the top button activates water delivery to clean distal objective lens - Fully depressing the both buttons delivers water into water injection channel to automatically fill balloon with water INSTRUMENT CHANNEL INLET: For introduction of biopsy forceps and other accessories.

SUCTION CHANNEL SELECTOR (Part # OF-B141) Alignment of the channel selector to the prescribed indicators ("S" or "B") allows the user a choice of suction capability through either instrument channel or balloon evacuation channel.

CONTROL BODY SERIAL NUMBER

R

MANUAL WATER INJECTION CONNECTOR Allows connection of special injection tube (Part # OF-B72) for manual filling of balloon with de-aerated water.

RIGHT/LEFT DEFLECTION CONTROL KNOB RIGHT/LEFT DEFLECTION LOCK: Functions similar to Up/Down lock. UP/DOWN DEFLECTION CONTROL KNOB

ELEVATOR CONTROL KNOB (FG- 36UX) To guide and direct forceps and other accessories. DIOPTER ADJUSTMENT RING: Adjustable for individual user's eyesight. SCANNER CONNECTOR CABLE

UMBILICAL CABLE

EYEPIECE FG-36UX ONLY ELECTRICAL CONTACTS For automatic exposure.

BAYONET PINS Guide pin for adapter lens and Observerscope.

OCULAR LENS

INFINITY FOCUS LOCKS Set the focus automatically when adapter lens or observerscope is attached. ELEVATOR WIRE CLEANING INLET The elevator wire and the elevator wire channel can be reprocessed with an appropriate solution administered through this inlet.

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ULTRASOUND GI FIBERSCOPE

FG-36UX

FG-34UX/38UX AIR/WATER FEEDING NOZZLE

GROOVES FOR BALLOON

INSTRUMENT CHANNEL

WATER INJECTION PORT

CONVEX ARRAY TRANSDUCER

OBJECTIVE LENS

LIGHT GUIDE

BALLOON EVACUATION CHANNEL

BENDING SECTION

ETO STERILIZATION VENTING CAP RED (MODEL: OF-C5): Provides venting of endoscope interior to equalize internal and external pressures.The cap must be removed before immersion. NOTE: See important separate section regarding the use of this cap!

CONVEX ARRAY TRANSDUCER

INSTRUMENT CHANNEL

WATER INJECTION PORT

BALLOON

VENTING CONNECTOR: Accepts 'RED' ETO Sterilization Venting Cap. Also accepts leakage tester.

AIR/WATER FEEDING NOZZLE

LIGHT GUIDE

ELEVATOR

BALLOON EVACUATION CHANNEL

GROOVES FOR BALLOON

OBJECTIVE LENS

BALLOON

DISTAL RIGID PORTION

SOAKING CAP SILVER (Model: OF-C3): When soaking, OF-C3 should be securely on the light guide plug covering the electrical pins. This cap must be attached before immersion.

SCANNING CONNECTOR LOCK Securely locks the scanning connector of the Pentax endoscope into the scanning unit (Hitachi Medical) to ensure proper contact with and functioning of the electronic circuitry.

Prior to immersion (or soaking) RED CAP – OFF SILVER CAP – ON

7.5MHz

SCANNING UNIT CONNECTOR Do NOT immerse this section.

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

LIGHT GUIDE CONNECTOR AIR/WATER CONNECTOR: To connect feeding tube from water bottle assembly.

SUCTION NIPPLE: For attachment to external suction source.

FEEDBACK TERMINAL Certain manufacturers' electrosurgical units, such as Olympus, require the connection of a scope feedback cord (S-cord) to this feedback terminal.

-3-

WARNING: 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 plastic light guide plug

1-2. ACCESSORIES 1) Biopsy Forceps ENHANCED FLEXIBLE PORTION

FLEXIBLE SHAFT

GRIP

HANDLE Pink handle defines autoclavable forceps

CUPS

2) Aspiration Needle SIDE PORT LUER NEEDLE TIP

STYLET TIP

3) Cleaning Brush WHITE BRISTLE

FLEXIBLE SHAFT

HANDLE CS6015ST for FG-34UX CS6021SN for FG-34UX/36UX/38UX

4) Suction Cylinder Cleaning Brush ( CS-C3S )

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.

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

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ULTRASOUND GI FIBERSCOPE

1-3. LIGHT SOURCE LX-750P LAMP BUTTON Pressing this button ignites the lamp.

PUMP HIGH/LOW SWITCH

WATER BOTTLE ASSEMBLY Acts as a reservoir for water to be delivered through scope. Set lever to air/water position during procedure.

PUMP ON/OFF SWITCH

COOLING FAN EXHAUST Operates as long as the powerswitch is turned ON.

LH-150PC

LIGHT GUIDE SOCKET Plug PENTAX scopes in this socket.

MAIN POWER SWITCH I : ON O : OFF AIR/WATER CONNECTOR Inserts into Air/Water socket of endoscope umbilical cable(light guide plug)

AIR/WATER-DRAIN LEVER AIR OUTLET

BRIGHTNESS CONTROL KNOB Brightness of observing field can be adjusted.

A/W DRAIN “DRAIN” will purge (drain) water in the water lines by allowing air flow only. “A/W” (= Air/Water) allows air and water feeding during procedure controlled by a Air/ Water valve on scope head.

WATER BOTTLE Should be 2/3 full with sterile water.

SCOPE LIGHT GUIDE SOCKET

LAMP HOUSING COVER Using a flat blade screw driver, open the cover to expose lamp housing for lamp replacement. Note: Following lamp replacement, properly position and fully secure the Lamp Housing Cover

AIR PUMP SWITCH Power switch must be on to activate Air Pump.

POWER SWITCH Activates main power.

CAUTION: Please refer to the instruction supplied with the light source

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2. PREPARATION AND INSPECTION FOR USE Prior to use, the endoscope, light source and accessories must be carefully inspected for cleanliness and proper function to determine that they are appropriate for patient use.

2-1. INSPECTION OF LIGHT SOURCE Please refer to the operating manual of the PENTAX light source involved for complete instructions. 1) Attach water bottle assembly, 2/3 filled with sterile water to the appropriate location on the light source.

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.

2) Set the drain lever on the water bottle assembly to the upright position, labeled A/W (air/water). 3) With the power switch in OFF position, plug light source into a properly grounded receptacle. PENTAX light sources have a hospital grade plug with a grounding conductor. 4) Depending upon the manufacturer, model and/or type of light source to be used, an adapter may be required to make a complete connection between source of illumination and PENTAX fiberscope. 5 a) The standard PENTAX adapter sleeve, OF-G1, included on PENTAX fiberscopes will allow connection to and light transmission from any PENTAX light source. For complete functional capabilities, including automatic exposure and/or auto brightness control, with certain model PENTAX light sources, an AL-E3 adapter will be required. a)

-6-

ULTRASOUND GI FIBERSCOPE

Using adapter AL-OLG9, PENTAX fiberscopes can be connected to Olympus CLV-U20 and all OES series light sources.

b) The silver soaking cap, OF-C3, may be left on the light guide plug when connecting a PENTAX fiberscope to a PENTAX light source. However, for automatic exposure and/or auto brightness control, the OF-C3 soaking cap must be removed. 6) Adapters are available to connect PENTAX fiberscopes to Olympus light sources. For assistance, please contact your local PENTAX distributor or service facility. 7) If a deluxe PENTAX light source with automatic exposure capability is used, set the exposure index to a proper setting. 8) Make sure the PENTAX light guide receptacle is properly aligned with the two indicators on the front panel of the light source. 9) Connect the endoscope light guide plug to the light source. 10) Connect the air/water feeding tube from the water bottle assembly to the air/water connector. 11) Turn the light source and the air pump to the “ON” position to check for proper functioning.

NOTE: For a light source other than PENTAX, be sure that the correct adapter (AL-OLG9, etc.) is being used.

WARNING: The risk of thermal injury exists whenever fiberoptic instruments are used with high intensity light sources. The risk of injury is greatest: a) When a high intensity Xenon light source is used. b) During close stationary observation and /or prolonged close contact with mucosa. c) When the fiberscope is advanced slowly through a narrow lumen. Close stationary viewing should be avoided and the level of illumination should be limited to the level necessary for adequate visualization.

-7-

2-2. INSPECTION OF FIBERSCOPE 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) • the forward water jet connector (4) • any valve cylinder (5) • 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)

GI Scope

Non-GI Scope

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 lint-free 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-

ULTRASOUND GI FIBERSCOPE

CAUTION: lf the endoscope is intended to be clinically used after testing of individual scope functions (suction, air/water delivery, 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 of the endoscope.

TE

ST

D

19.6

0

GER

LEKAGE TESTER SHA-P2

AN

29.4 9.8

39.2

kPa(kg/cm2)

Leakage Tester

Before proceeding with inspection of individual functions, PENTAX Fiberscopes 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 Tester Instructions.” 1) Inspection of the Insertion Tube a) Check the entire surface of the insertion tube for abnormal conditions such as dents, wrinkles, or bite marks. Any indentation of the flexible shaft of the fiberscope can cause damage to the internal mechanisms of the fiberscope. b) Similarly, check the condition of the umbilical cable for outward signs of damage such as buckling, crush marks, etc.

CAUTION: To avoid further damage to the fiberscope or the possibility of malfunction during a procedure, do not use any fiberscope with outward signs of damage.

c) Make sure that the entire fiberscope is clean and has been subjected to either a high-level disinfection or sterilization process before each patient use.

NOTE: The distal end of the fiberscope must be protected against damage from impact. Never apply excess force such as twisting, or severe bending to the flexible portion of the fiberscope.

RIGHT-LEFT 120°-120°

UP-DOWN 130°-130°

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.

-9-

b) Engage the deflection locks to be certain that the position of the deflected tip can be stabilized.

NOTE:

Cover hole

Press top Press both button buttons

Air Feeding

Water Feeding

Balloon Feeding

OF-B123

O-Ring set OF-B128

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. Any lack of smooth operation of the deflection control may be an indication of internal damage to the fiberscope. To avoid the possibility of further damage to the fiberscope or the possibility of malfunction during a procedure, do not use the fiberscope, if the angulation mechanism does not operate smoothly.

3) Inspection of Air/Water/Balloon Feeding a) To inspect air delivery, cover the hole at the top of the air/water/ balloon feeding valve so that air flows freely from the nozzle at the distal tip of the endoscope. b) By depressing the top button of air/water/balloon feeding valve, the water delivery system is activated. Water should flow in a steady stream from the nozzle at the distal tip of the endoscope (this may take several seconds on the initial attempt). Use sterile water only. c) Fully depressing the both buttons of air/water/ balloon feeding valve, the delivery system to fill the balloon with water is activated. Water should flow in a steady stream from the water injection port at the distal tip of the endoscope (this may take several seconds on the initial attempt). d) Release the air/water/balloon feeding valve to determine if the valve freely returns to its OFF (neutral) position and delivery of water ceases. e) If the air/water/balloon feeding valve does not move smoothly, remove the valve from the air/ water cylinder on the control body of the endoscope. Apply a small amount of silicone oil lubricant, OF-Z11, onto all rubber O-rings. Remove/wipe off excess lubricant with a soft gauze. Do not use excessive silicone oil.

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

f) If air and/or water do not flow properly, NEVER attempt to clear the air/water nozzles with a needle or any other sharp object. Instead, the following steps should be followed:

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ULTRASOUND GI FIBERSCOPE 1 Disconnect the endoscope from the light source. 2 Turn the threaded portion of the air/water/

balloon feeding valve counterclockwise and remove the valve. 3 Using a cotton tip applicator and alcohol, clean the valve recess in the control body thoroughly 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. 4 Clean the air/water/balloon feeding valve assembly thoroughly and rinse well. 5 As illustrated, install the adapters Part OF-BG3 provided as the air/water/water injection channel cleaning adapter. 6 The adapter illustrated as B in the figure has a luer lock connector to which a syringe should be attached. Alcohol or a compatible enzymatic detergent solution should be flushed through this connection and will flow through both the air and water tubing and nozzles of the endoscope. Soaking of these channels with detergent solution should dissolve and dislodge whatever is restricting the normal delivery of air or water. Fill the syringe with air and flush through the endoscope several times to force any residual solution out of the tubing and nozzles.

OF-BG3 FO

A

3 BG

B

NOTE: The following alternate method should only be used on a partially occluded air or water channel. Do NOT use high pressure on a completely clogged channel/nozzle as excessive pressure could result in scope damage. The adapter illustrated as A in the figure allows simultaneous flushing of air, water and water injection channels. To direct pressurized fluid (or air) separately to each channel, leave the air/ water/balloon feeding valve attached to the cylinder instead of using A. Then follow instructions for connecting syringe to adapter as illustrated B in the figure at left. Pressure can be directed to the air system by covering the hole in the air/water/balloon feeding valve. For flushing of the water line, the top button in the air/water/ balloon feeding valve must be depressed with the hole covered. For flushing of the water line for the water injection port, both buttons in the air/water/ balloon feeding valve must be fully depressed with the hole covered.

- 11 -

NOTE: Thoroughly dry the air and water channels of the scope. 70% alcohol followed by compressed air, not greater than 165 kPa (1,69 kg/cm2, 24 PSI), may be used to facilitate drying via the adapter. 7 Remove the adapters used in step 6 and install

the air/water/balloon feeding valve. Test for normal delivery of air and water. It may be necessary to repeat the procedure outlined in steps 5 & 6 if normal air and water delivery is still not available.

CAUTION: 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 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.

INJECTION TUBE (OF-B72)

4) Inspection of manual water injection (balloon filling) a) Attach the injection tube (Part #OF-B72) to the water injection connector on the bottom of the control head. b) Attach a syringe filled with sterile water to the stopcock on the injection tube, open the stopcock and then inject water. Make sure that water freely exits the injection port at the distal end of the scope (this may take several seconds on the initial attempt). c) If water does not flow properly, NEVER attempt to clear the injection port with a needle or any other sharp object. Instead, the following steps should be followed: The air/water/balloon feeding valve should be in place. 1 Attach a syringe filled with a compatible enzymatic detergent solution to the irrigation tube. 2 Open the stopcock and flush detergent solution through the tube and nozzle. Soaking of the channel with enzymatic detergent solution should help dissolve and dislodge whatever is restricting the normal forceful stream from the injection port.

- 12 -

ULTRASOUND GI FIBERSCOPE Remove the syringe with detergent solution and attach a syringe filled with air. Flush air through the injection tube and port several times to remove any residual detergent solution from the tubing and nozzle. Follow by a water rinse. 4 It may be necessary to repeat set 1, 2, 3 several times to obtain proper water dispensing function. 3

CAUTION: If repeated attempts to flush the injection channel and distal port are unsuccessful, contact the PENTAX Service Department.

WARNING: Elevator Control Knob

INSTRUMENT CHANNEL SELECTOR

S

B

“B” INDICATOR

Although the manual water injection system may not be clinically used during each procedure, it still MUST be properly cleaned and subjected to the same disinfection/sterilization processes as other internal channels of the fiberscope.

5) Inspection of Elevator (FG-36UX ONLY) This is the control that will guide and direct either the biopsy forceps or other accessory during a procedure. To inspect, push elevator control knob forward with thumb of the left hand. The elevator in the distal tip should elevate in proportion to the distance the control knob is moved. The motion of the elevator and the knob should be smooth and easy without any “play” involved.

WARNING: As with all other internal channels of the endoscope, the elevator wire channel must have been properly cleaned and subjected to an appropriate high-level disinfection or sterilization process before each use.

“S” INDICATOR

INSTRUMENT CHANNEL

FG-36UX

INSTRUMENT CHANNEL

FG-34UX FG-38UX

6) Inspection of Instrument Channel Selection a) Check the condition of the instrument channel selector. The selector knob should move smoothly when rotated, and click into position at the prescribed colored indicators, labeled “B” for balloon or “S” for suction of main instrument channel. The instrument channel selector allows the user the choice of suction capability through either the instrument channel or balloon evacuation channel. b) Alignment of the instrument channel selector to the indicator labeled “S” allows aspiration through the main instrument channel. Rotation of the channel selector to the “B” indicator allows aspiration/ evacuation of water and air from the balloon.

- 13 -

NOTE: Suctioning via the balloon evacuation channel (identified by the letter “B”) is intended for evacuation and removal of de-aerated water from the balloon during the balloon contact method of sonographic imaging. Aspiration of body fluids should only be performed through the main instrument channel (“S” indicator) as mucous, debris, etc. could create a blockage in the smaller water injection channel.

GUIDE TAB SELECTOR CYLINDER NOTCH

c) Should the suction channel selector not rotate smoothly, it might require further cleaning. 1 Rotate counterclockwise the knurled section of the selector (area ), and remove the entire suction channel selector mechanism from the selector cylinder. 2 Using the suction cylinder cleaning brush, CS-C3S, insert the brush into the opening of the suction channel selector cylinder. Thoroughly clean the surface areas.

DEPRESS

3 Next, thoroughly clean the suction channel

selector and rinse well.

SUCTION TUBE SUCTION NIPPLE

Silicone oil

7) Inspection of Suction Mechanism a) Connect suction tubing from an external suction source to the suction nipple located on the light guide plug at the end of the umbilical cable. Place the distal tip of the endoscope in sterile water and depress the suction control valve. Water should be rapidly aspirated into the suction system collection container. b) Release the suction control valve to determine if the valve freely returns to its OFF position and the aspiration of water ceases. c) If the suction valve does not move smoothly, 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 all rubber O-rings. Remove/wipe off excess lubricant with a soft gauze. Do not use excessive silicone oil.

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: Rubber inlet seals in good condition must be on the instrument channel inlet to prevent the loss of suction. Worn seals will result in leakage and the possible crosscontamination due to the possible reflux or spit back of patient fluids. Worn seals should be replaced.

- 14 -

ULTRASOUND GI FIBERSCOPE

CLOSE OPEN

8) 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. 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.

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.

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.

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: The instrument channel is 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..

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

- 15 -

2-3. PREPARATION OF ULTRASOUND SCANNING UNIT 1) The following model ultrasound scanners are currently compatible with the PENTAX convex array ultrasound endoscopes. Hitachi Medical Corporation In U.S.A

Model EUB-525, Model EUB-6000

Outside U.S.A

Model EUB-525, Model EUB-6000, Model EUB-6500

NOTE: If the above model scanning units have been purchased separately from the PENTAX ultrasound endoscope, minor modifications to the scanners may be required to ensure complete compatibility. Should you have any questions on this subject, please contact your local sales representative.

2) For complete details on the handing, operation, care and maintenance, etc. of the ultrasound scanning units, refer to the user's manual provided with each unit.

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ULTRASOUND GI FIBERSCOPE

2-4. PREPARATION BEFORE THE EXAMINATION NOTE: The latex balloons and O-Rings are disposable. They are provided sterile for single patient use.

WARNING: Please be advised that PENTAX balloons, are made of latex material and the O-ring contains thiuram. Appropriate precautions, are therefore, recommended. Due to the potential severe allergic reactions to medical devices containing latex (natural rubber) and thiuram, healthcare professionals are encouraged to indentify latex/ thiuram sensitive patients and be prepared to treat allergic reactions promptly.

A. Procedures using Balloon Method

NOTE: When attaching or removing the latex balloon, be careful not to damage the endoscope, especially the sensitive transducer (curved area), optical lenses or bending section at the distal portion.

O-Ring (Large)

O-Ring (Small)

1) Connect the Scanning Unit Connector to the Ultrasound Scanning Unit. 2) Prior to attempting to secure the latex balloon to the scope, moisten both balloon and scope tip with sterile water. This will create a more slippery surface to allow easier sliding of the balloon over the transducer at the distal end of the scope. 3) Carefully attach the balloon provided onto the tip of the endoscope. Gently slide the balloon over the distal end of the scope and place the balloon band into the groove at the scope tip. 4) Slide the larger rubber band (O-ring) onto the balloon installation device. Place the installation device over the balloon so that when the large O-ring (rubber band) is pushed off the device it will fall securely around the balloon into the groove on the scope tip. 5) Then place the smaller rubber band into the groove at the distal tip. 6) (Optional method) Instead of using the provided rubber bands to secure the distal balloon, the user may opt to use suture thread to secure attachment.

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7) To check the integrity of the balloon, inflate it with air in the following manner. (7-1) Manual Balloon Filling (with syringe) 1 Attach the injection tube (Part #OF-B72) to the

water injection connector located at the bottom of the control head. 2 With the stopcock open on the injection tube and a syringe attached, inject air into the bottom. 3 Check to ensure that the balloon expands normally, maintains its shape and there are no pinholes. (The inflated balloon may be placed in sterile water to confirm that there is no leakage.) 4 Once the integrity of the balloon has been confirmed, remove air and allow the balloon to shrink down to its original size. (7-2) Automated Balloon Filling (with air/water/ balloon feeding valve and water bottle)

OF-B72

NOTE: A good inlet seal must be attached to this injection connector (female luer lock fitting) prior to attempting automated filling of the balloon. 1 Close the valve of the OF-B72 or just remove

FG-34UX/38UX

the OF-B72 2 Ensure that the water bottle assembly for the light source (or video processor) has been filled (2/3 full) with sterile water. Connect the bottle tube to the endoscope.

Water Injection Port/ Balloon Evacuation Port

3 Fully depressing the air/water/balloon feeding

Air

valve all the way down should activate water delivery to the balloon. Gradually fill the balloon with no more than 15mL of water. De-Aerated Water

NOTE: Do not overfill the balloon with water. The maximum volume of water should not exceed 15mL. Confirm the distension of balloon by monitoring the volume of water injected and by observing the sonographic image.

FG-36UX Water Injection Port

Balloon Evacuation Port Air

NOTE: If any air remains trapped within the balloon, it may be removed as follows i) Position the scope distal tip so that the entrapped air rises above the water surface and is in contact with the balloon evacuation port. See figure at left. ii) Proceed to evacuate the excess air using an aspirator as described in section “Directions for use”

De-Aerated Water

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