EG-3870UTK and EG-3670URK Instructions for Use March 2012

Intended Use PENTAX ultrasound endoscopes are intended to provide optical and ultrasonic 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 and Duodenum. These 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 these endoscopes for any purpose other than that for which they have been designed. These video endoscopes contained in this instructions for use can be used with PENTAX video processors EPK-i5000, EPK-i, EPK-100p, or EPK-1000.

Notes Read this instructions for use (IFU) before operating and save this IFU 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 may result in damage to, and/or malfunction of, the equipment. This IFU 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 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 users 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 users 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. 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 representative.

Sterility Statement The instruments identified in this IFU 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. After servicing, these endoscopes and those components must be reprocessed prior to clinical use.

Contraindication Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order to reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on patients afflicted with Creutzfeldt-Jacob Disease (CJD or vCJD).

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

WARNING:

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.

TABLE OF CONTENTS 1. NOMENCLATURE AND FUNCTION ... 4 1-1. Video endoscope ... 4 1-2. Accessories ... 6 1-3. Video Processor ... 7

2. PREPARATION AND INSPECTION FOR USE ... 9 2-1. Inspection of the Video Processor ... 9 2-2. Inspection of Endoscope ... 11 2-3. Preparation of Ultrasound Scanning Unit ... 23 2-4. Preparation before the Examination ... 23 2-5. Preparation just before Insertion of Endoscope ... 26

3. DIRECTIONS FOR USE ... 28 3-1. Pretreatment ... 29 3-2. Insertion and Withdrawal ... 29 3-3. Precise Accessory Control (For EG-3870UTK only) ... 33 3-4. Biopsy ... 33

4. CARE AFTER USE ... 39 4-1. Internal Channels of PENTAX endoscopes ... 40 4-2. Reprocessing System ... 44 4-3. Endoscopes ... 46 4-3-1. Pre-Cleaning ... 46 4-3-2. Leakage Testing ... 48 4-3-3. Cleaning ... 48 4-3-4. High-Level Disinfection ... 67 4-3-5. Sterilization ... 78 4-4. Endscopic Accessory Instruments (EAIs) and Endoscope Components ... 80 4-4-1. Cleaning ... 80 4-4-2. High-Level Disinfection ... 82 4-4-3. Sterilization ... 83 4-5. Water Bottle Assembly ... 85

5. POST REPROCESSING ... 87 5-1. Servicing ... 88 5-2. Care and Maintenance Tips ... 90

1. NOMENCLATURE AND FUNCTION 1-1. Video endoscope SUCTION CONTROL VALVE (OF-B171) Depress to remove fluids or air through the instrument channel or aspirate air or water from the balloon. For details, refer to “6) Inspection of Suction Mechanism (on page 20)”.

AIR/WATER/BALLOON FEEDING VALVE (OF-B172): To control air/water delivery. For details, refer to “4) Inspection of Air/Water/Balloon Feeding Mechanism (on page 17)”.

RUBBER INLET SEAL (OF-B190) INSTRUMENT CHANNEL INLET For introduction of biopsy forceps and other accessories.

CONTROL BODY BUTTON 1 Push to freeze an image.

RUBBER STRAIN RELIEF

BUTTON 2 Push to activate the hardcopy system that was selected between “File” and “HARD COPY”.

(EG-3870UTK) ELEVATOR WIRE CLEANING INLET CAP (OE-B3)

(EG-3870UTK) ELEVATOR WIRE CHANNEL INLET The elevator wire and the elevator wire channel can easily be reprocessed with an appropriate solution administered through this inlet.

RIGHT/LEFTANGULATION LOCK: Functions similar to Up/Down Angulation Lock.

UP/DOWN ANGULATION 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.

UP/DOWN ANGULATION CONTROL KNOB

RUBBER STRAIN RELIEF BUTTON 4 Push to change the intensity of enhancement that was previously assigned.

SCANNER CONNECTOR CABLE

(EG-3870UTK) ELEVATOR CONTROL KNOB To guide and direct forceps and other accessories.

BUTTON 3 Push to activate the VCR for recording live procedures.

UMBILICAL CABLE

RUBBER STRAIN RELIEF

NOTE: Function of each button depends upon the processor. The function can be changed. For more details, refer to the manual supplied with the processor. The table below shows the factory setting. EPK-i5000

EPK-i

EPK-1000

EPK-100p Freeze

Button 1

Freeze

Freeze

Freeze

Button 2

Peripheral

Hard Copy

Hard Copy

Button 3

AVE/PEAK

VCR

Button 4

Enhance

Enhance

VCR (for NTSC) Enhance (for PAL) Enhance (for NTSC) AVE/PEAK (for PAL)

–4–

Enhance AVE/PEAK

NOTE:

NOTE: To avoid damaging the endoscope, do NOT twist, rotate or bend excessively any of the rubber strain reliefs.The rubber strain reliefs of endoscopes with split (bifurcated) umbilical cables should never be grasped together or pressed firmly against each other to avoid the potential for scope damage in these areas.

Function of each button can be changed by the processor. For more details, refer to the manual supplied with the processor.

WARNING: NEVER perform electro-surgery with these endoscopes.

DISTAL END BENDING SECTION

INSERTION TUBE RUBBER STRAIN RELIEF

SCANNING UNIT 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. SCANNING UNIT CONNECTOR CAUTION: Do NOT immerse it without the soaking cap.

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

SCANNING UNIT CONNECTOR SOAKING CAP (Model OE-U1) CAUTION: Prior to immersion this cap must be attached to the scanning unit connector.

VENTING CONNECTOR Accepts “RED” ETO GAS Sterilization Venting Cap and Leakage Tester.

ETO GAS STERILIZATION VENTING CAP RED (Model 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! (p. 44, 45, 49, 67, 78)

PVE CONNECTOR Can be rotated within a 180° range.

RUBBER STRAIN RELIEF FEEDBACK TERMINAL NOT USED TO THESE SCOPES SUCTION NIPPLE For attachment to external suction source.

PVE SOAKING CAP (Model OE-C9) This cap must be securely atached to the electrical contact before immersion.

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

NOTE: 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.

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 PVE connector housing.

–5–

1-2. Accessories 1)

Biopsy Forceps (1) Enhanced Flexible Portion (2) Flexible Shaft (3) Grip (4) Handle (5) Cups

Figure 1.1

2)

Aspiration Needle (For EG-3870UTK)

(1)

(2)

(4)

(3)

(5)

(1) Needle (2) Flexible Shaft (3) Handle (4) Proximal End (5) Luer Lock(Female)

Figure 1.2

3)

Cleaning Brush (1) Back End (Blue) (2) (CS6021T) (2)

(1)

Figure 1.3

This brush is provided non-sterile for one time use. NEVER reuse this disposable brush on more than one instrument. 4)

Cleaning Brush for Air/Water Suction Valve (OF-B172) Cylinder (1) (CS-C9S) (1)

Figure 1.4

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, the accessory manufacturer should be consulted to confirm compatibility with PENTAX endoscopes before use. • 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.

–6–

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.

1-3. Video Processor NOTE: Please read the instructions for use supplied with the processor. WARNING: Do not install, operate or store electro-medical equipment in a dusty environment. Accumulation of dust within these units may cause malfunction, smoke, or ignition.

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 molded-in model designation. Ensure that an OS-H4 cap is used only with the OS-H4 water container/bottle. Do NOT overtighten the bottle cap. Overtightening can cause the bottle cap to break.

(1) EPK-i5000/EPK-i

(1) (2)

(5)

(4)

Figure 1.5

–7–

(3)

(1) Endoscope Electrical Connector (2) Lamp Switch (3) Light Guide Attachment (4) Power Switch (5) Water Bottle

WARNING: The lamp life for EPK-i5000 is 500 hours. Check the lamp life indicator on the touch panel before you use the processor. Replace the lamp cartridge if one of the bars on the LIFE indicator lights red and the [Please replace the lamp] message appears on the monitor. The lamp life could be affected by frequency of use. In which case, the lamp life might become shorter than 500 hours.

NOTE: Software update may be required depending on the software version of the EPK-i5000 processor. If the software is not updated, the image will not be displayed. If the images are not displayed correctly, please contact your local PENTAX service facility.

(2) EPK-1000/EPK-100p (1) (2)

(3)

(1) Endoscope Electrical Connector (2) Air Pump Switch (3) Power Switch I : ON O: OFF (4) Lamp Switch (5) Light Guide Attachment (6) Water Bottle

(4)

(6)

(5)

Figure 1.6

WARNING: The lamp life when used in this equipment is 400 hours. Prior to use, check the lamp life indicator on the front panel to ensure the indicator is lit green or yellow. After 400 hours of use, the indicator turns red and the image quality will deteriorate. Excessive use of the lamp beyond its rated 400 hours (approaching a thousand hours of use or more) could cause the lamp to explode resulting in damage to the video processor.

NOTE: The lamp life could be affected by frequency of use. In which case, the lamp life might become shorter than 400 hours.

–8–

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: NOTE: PENTAX video endoscopes contained in this instructions for use are compatible with PENTAX video processors, EPK-i5000, EPK-i, EPK-100p, and EPK-1000.

2-1. Inspection of the Video Processor Please refer to the instructions for use of the specific model of PENTAX video processor for complete instructions. 1)

Attach water bottle assembly, 2/3 filled with de-aerated sterile water to the appropriate location on the left side of the video processor. 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) 3) 4) 5)

Set the drain lever on the water bottle assembly to the upright position labelled A/W (air/water). Plug the processor into a properly grounded receptacle with the power switch in the OFF position. Make sure that the PENTAX PVE connector is aligned with the interface socket on the front panel of the processor. Connect the endoscope to the interface socket on the processor as illustrated.

–9–

(1) Air/Water Feeding Tube

EPK-1000/EPK-100p

EPK-1000

(1) EPK-i5000

(1)

Figure 2.1

6)

Rotate the lever of the interface socket clockwise after insertion. CAUTION: After connecting the video endoscope to the video processor, always make sure that the endoscope is firmly secured to the endoscope receptacle by turning the locking lever to the “lock” position.

7) 8) 9)

Connect the air/water feeding tube from the water bottle assembly to the air/ water port on the side of the PVE connector. Turn the processor and air pump to the “ON” position and check for proper functioning. 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.

– 10 –

2-2. Inspection of Endoscope CAUTION: If the endoscope is intended to be clinically used after testing of individual endoscope functions (suction, air/water delivery, etc.) without further reprocessing, the following precaution should be exercised. Use “fresh” distilled or sterile water during individual endoscope 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.

Before reprocessing and/or immersion in any fluids, PENTAX endoscopes should be tested for the loss of integrity in their watertight construction by using PENTAX brand leak testers. For specific details on PENTAX recommended leak detection procedures, please refer to the instructions supplied with PENTAX leak testers. 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)/Washers-Disinfectors (WDs). It must be recognized that PENTAX does not evaluate non-PENTAX leak tester systems to satisfy their specific product claims, for their effectiveness to accurately detect leaks and/or for their compatibility with PENTAX endoscopes. Insufficient pressures may reduce the likelihood for accurate leak detection, especially if the endoscope’s distal bending section is not flexed during testing. Excessive 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 leak 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 endoscope’s distal bending section.

1)

Inspection of the Insertion Tube a) Check the entire surface of the insertion tube for abnormal conditions such as dents, crush marks, wrinkles, 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) Also check the condition of the scanning unit cable for any outward signs of damage.

– 11 –

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

d) These areas [A], [B] should be checked for ANY abnormalities or irregularities. If anything unusual is found including but not limited to rough textured surfaces, cracks, brittleness, sharp-edges, holes, peeling, tackiness, etc., the endoscope should NOT BE USED. During this inspection process check the surface/condition of the adhesive by applying slight pressure with one's gloved fingers and by slightly wiping this area with dry gauze. Make sure the glue is not peeling, nor does it have roughened texture or any sharp-edges. (3)

(4)

(2)

(1)

(1) Bending Section (2) Close-Up View (3) Black adhesive band [A] (4) Black adhesive band [B]

Figure 2.2

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

– 12 –

2)

Inspection of insertion tube flexibility NOTE: Perform this process as part of the pre-use inspection of the endoscope.

CAUTION: When performing this inspection, ensure that other components of the endoscope (Distal End, Control Body, etc.) are not damaged by impact to surfaces or objects in the area. Do NOT adjust the Bending Section of the endoscope as part of this inspection. Maintain the distal end in a straight orientation. • Hold the Insertion Tube at the junction of the Insertion Tube and Bending Section, • Do not close your hand around the Bending Section.

Inspection Process a) Starting at the Bending Section junction, create a 50 cm loop of the Insertion Tube as shown in the figure below.

Figure 2.3

b) Gently raise/lower the left/right hands alternately and confirm equal flexibility for the length of the loop. Do NOT use the endoscope if there are any: • extraordinarily rigid portion which do not bend as easily as the rest of the loop or • extraordinarily flexible portions which bend much more than the rest of the loop.

Figure 2.4

– 13 –

Figure 2.5

c) Repeat steps a and b above until the inspection of the entire insertion tube is complete. If the endoscope fails the inspection above: Do NOT use the endoscope and Contact your PENTAX representative. NOTE: • The distal end as well as the electrical contacts/pins on the PVE connector and scanning unit connector of the endoscope must be protected against damage from impact. NEVER apply excess force such as twisting, or severe bending to the flexible portion of the endoscope. • As indicated elsewhere in PENTAX product labelling, endoscopes particularly the quality of the endoscopic image should be checked prior to patient use. Similarly the quality of the ultrasound image should be checked. • During pre-use inspection, ensure that the distal objective lens and the illumination (LCD) cover glass are clean and no residues are present on these distal surfaces. If not, crisp images can NOT be displayed. Wipe them with a gauze or the like moistend with 70-90% medical grade ethyl or isopropyl alcohol. • Ideally all patients should be prepped well to maximize visualization of the intended areas of interest. Patient material and secretions 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 possible. • Continued use of the endoscope’s light guide lens system covered with adhering patient material might cause a visible steam-like vaporization associated with moisture loss from heated organic material clinging to the distal LCB lens surface. If this vapor is observed during a procedure, stop it immediately, withdraw the endoscope from patient and clean off any foreign material clinging to the endoscope lens/tip.

– 14 –

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, endoscope 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) • the elevator wire cleaning inlet (5) (For EG-3870UTK) • basically, any inlet or outlet port associated with an internal channel, an indirect patient contact portion of the endoscope (4)

(1)

(5)

(3) (2)

Figure 2.6

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 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.

– 15 –

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.

Do NOT Twist or Rotate

Do NOT Bend

(1)

(2)

(2)

Figure 2.7

3)

Inspection of Angulation 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 angulation is possible. b) Engage the angulation locks to be certain that the position of the angulated tip can be stabilized. NOTE: The angulation 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.

– 16 –

CAUTION: ANY lack of smooth operation of the angulation 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 angulation 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 ANGULATION 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 angulation. 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. (1) OF-B172 (2) O-ring Set (OF-B191)

(1)

(2)

Figure 2.8

4)

Inspection of Air/Water/Balloon Feeding Mechanism a) Prior to use, the air/water/balloon feeding valve, OF-B172, should be inspected. Remove the valve from control body. Make sure that O-rings are in good condition and are properly attached and lubricated with a small amount of OF-Z11 silicone oil. WARNING: A worn or damaged valve and/or O-rings should be replaced with a new one. The entire valve mechanism should be subjected to a high-level disinfection or sterilization procedure prior to use (O-ring set, model OF-B191, is optionally available). For repeated use, always ensure that the valve and/or O-rings have already been reprocessed. A damaged or worn valve and/or O-rings could create continuous air flow or excessive air insufflation and result in potential patient injury such as pneumatic perforation or could create a risk of cross contamination to the end user due to the potential for reflux (spit-back) of patient fluids out of the valve.

– 17 –

(1)

(2)

(3)

(4)

(5)

(1) Action (2) Result (3) Air Feeding (4) Water Feeding (First Stage) (5) Water Feeding to the balloon (Second Stage)

Figure 2.9

b) To inspect air delivery, cover the hole at the top of the OF-B172 and confirm that air flows freely from the endoscope distal tip. c) By depressing the top button of OF-B172, the water delivery system is activated. Water should flow in a steady stream from the distal tip of the endoscope. (This may take several seconds on the initial attempt.) USE DE-AERATED STERILE WATER ONLY. d) By fully depressing both buttons of OF-B172, 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). e) Release the air/water/balloon feeding valve to determine if the valve freely returns to its OFF (neutral) position and delivery of water (and air) ceases. f) If the air/water/balloon feeding valve does not move smoothly, remove the valve and apply a small amount of silicone oil lubricant onto all the O-rings. Remove/wipe off excessive 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/Water/Suction channel and potential impairment of the normally clear endoscopic image.

g) If air and/or water do not flow properly, NEVER attempt to clear any of the distal channel openings with a needle or any other sharp object. Instead, the following steps should be followed. [1] EG-3670URK [a] Disconnect the endoscope from the video processor. [b] Remove the air/water/balloon feeding valve (OF-B172). [c] Using a cotton tipped applicator and alcohol, clean the valve recess (receptacle) 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 and cause channel blockage. [d] Clean the air/water/balloon feeding valve (OF-B171) assembly thoroughly and rinse well.

– 18 –

(2)

(1)

(1) Instrument Channel Cleaning Adapter (OE-C5) (2) Air/Water/Instrument Channel Cleaning Adapter (OF-B153)

Figure 2.10

[e] [f]

Remove the suction control valve, and install the adapters as illustrated. After attaching the adapters as illustrated, follow the section of this instructions for use for cleaning the Air/Water/Suction channel.

NOTE: Thoroughly dry the air and water channels of the endoscope. 70-90% medical grade ethyl or isopropyl 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.

[g]

Remove the adapters used in step [f] 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 [e] & [f] if normal air and water delivery is still not available. [2] EG-3870UTK Follow the reprocessing instructions as described in section 4. CARE AFTER USE. 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 facility.

5)

Inspection of Elevator 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. (1) Elevator (2) Elevator Control Knob (1)

(2)

Figure 2.11

– 19 –

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.

6)

Inspection of Suction Mechanism (1) Depress (2) Suction Tube (3) Suction Nipple

(1)

(2) (3)

Figure 2.12

a) Prior to use, the suction control valve, OF-B171 should be inspected. Remove the valve from the control body and ensure that rubber O-rings are in good condition are properly attached and are lubricated with a small amount of OF-Z11 Silicone Oil. (1) OF-B171 (2) O-Ring (Large) (3) O-Ring (Small) (4) O-Ring Set (OF-B187)

(1)

(2) (4) (3) Figure 2.13

WARNING: A worn or damaged valve and/or O-rings should be replaced with a new one. The entire valve mechanism should be subjected to a high-level disinfection or sterilization procedure prior to use (O-ring set, model OF-B187, 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 endoscope 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.

b) 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. c) Fully depress and then release the suction control valve to determine if the valve freely returns to its OFF position and the aspiration of water ceases.

– 20 –