FNL-7, 10 and 15 series NASO-PHARYNGO-LARYNGOSCOPE Owners Manual Jan 2006

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 These Naso-Pharyngo-Laryngoscopes are intended to provide optical visualization of, and therapeutic access to, the Upper Airway. The Upper Airway includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal passage, Trachea and Bronchial Tree. These instruments are introduced per orally or per nasally 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. 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 and hemorrhage. Current infection control guidelines require that Naso-Pharyngo-Laryngoscopes and other semi-critical medical devices, that normally come into contact with intact mucous membranes, such as in the Upper Airway, 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 federal and local regulations, and encourages users to follow infection control guidelines developed by various organizations for health care professionals.

NASO-PHARYNGO-LARYNGOSCOPES

TABLE OF CONTENTS 1.

2.

3.

4.

NOMENCLATURE AND FUNCTION...

2

1-1. FIBERSCOPE...

2

1-2. ACCESSORIES (FNL-15RP3/13RAP/10RAP)...

8

1-3. LIGHT SOURCE...

9

PREPARATION AND INSPECTION FOR USE... 10 2-1. INSPECTION OF LIGHT SOURCE...

10

2-2. INSPECTION OF FIBERSCOPE...

11

2-3. PREPARATION JUST BEFORE INSERTION OF FIBERSCOPE...

15

DIRECTIONS FOR USE... 16 3-1. PRETREATMENT...

16

3-2. INSERTION AND WITHDRAWAL...

16

3-3. BIOPSY (FNL-15RP3/13RAP/10RAP)...

17

CARE AFTER USE... 18 4-1. CARE AFTER EACH PROCEDURE... 4-1-1 PRE-CLEANING AT THE EXAMINATION ROOM... 4-1-2 CLEANING AT THE WORK ROOM... 4-1-3 CLEANING OF ACCESSORIES... 4-1-4 INTERNAL CHANNELS (FNL-15RP3/13RAP/10RAP)... 4-1-5 HIGH-LEVEL DISINFECTION... 4-1-6 DISINFECTION OF ACCESSORIES... 4-1-7 STERILIZATION AND AERATION... 4-1-8 STERILIZATION OF ACCESSORIES...

19 19 19 22 23 26 28 29 31

4-2. POST REPROCESSING...

32

4-3. SERVICING...

32

4-4. CARE AND MAINTENANCE TIPS...

33

LEAKAGE TESTER INSTRUCTIONS... 35 SPECIFICATIONS

WARNING: Instrument repairs should only be performed by an authorized PENTAX service facility. PENTAX assumes no liability for any patient/user injury, instrument damage or malfunction, or REPROCESSING FAILURE due to repairs made by unauthorized personnel.

WARNING: Never drop this equipment or subject it to severe impact as it could compromise the functionality and/or safety of the unit. Should this equipment to be mishandled or dropped, do not use it. Return it to an authorized PENTAX service facility for inspection or repair.

1. NOMENCLATURE AND FUNCTION 1-1. FIBERSCOPE (1) FNL – 7RP3/10RP3: Universal Rigid Style Ocular

DIOPTER POSITION MARKS (WHITE) Must be aligned to ensure proper focus for photography and use with an assistant’s observerscope.

DIOPTER ADJUSTMENT RING Adjustable for individual’s eyesight.

IMMERSIBLE MARKING The blue line here indicates the scope is fully immersible.

UMBILICAL CABLE

D U

MODEL PLATE

DEFLECTION CONTROL LEVER Deflects the distal end. EYEPIECE

OCULAR LENS

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NASO-PHARYNGO-LARYNGOSCOPES

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!

VENTING CONNECTOR Accepts “RED” ETO sterilization venting cap. Also accepts leakage tester. LIGHT GUIDE The standard PENTAX sleeve Model OF-G1 is already attached to these instruments. Various adapter sleeves for other manufacturer’s light sources are also available. (See page 10)

BENDING SECTION

IO INSERT

N TUBE

DISTAL END FNL-7RP3/10RP3 LIGHT GUIDE OBJECTIVE LENS

WARNING: Immediately after use, the metal light guide prong 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.

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(2) FNL – 15RP3: Universal Rigid Style Ocular

SUCTION NIPPLE For attachment to external suction source.

DIOPTER POSITION MARKS (WHITE) Must be aligned to ensure proper focus for photography and use with an assistant’s observerscope.

IMMERSIBLE MARKING The blue line here indicates the scope is fully immersible. DIOPTER ADJUSTMENT RING Adjustable for individual’s eyesight.

SUCTION CONTROL VALVE (MODEL: OF-B58) Press down to aspirate through the instrument channel.

UMBILICAL CABLE

D U

INSTRUMENT CHANNEL INLET For introduction of biopsy forceps and other accessories.

DEFLECTION CONTROL LEVER Deflects the distal end.

EYEPEACE

OCULAR LENS

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NASO-PHARYNGO-LARYNGOSCOPES

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!

RUBBER INLET SEAL (MODEL: OF-B70) Allows passage of accessories while preventing escape of fluids and air. VENTING CONNECTOR Accepts “RED” ETO sterilization venting cap. Also accepts leakage tester.

LIGHT GUIDE The standard PENTAX sleeve Model OF-G1 is already attached to these instruments. Various adapter sleeves for other manufacturer’s light sources are also available. (See page 10)

BENDING SECTION

N TUBE INSERTIO

DISTAL END

OBJECTIVE LENS

INSTRUMENT CHANNEL

LIGHT GUIDE

WARNING: Immediately after use, the metal light guide prong 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.

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(3) FNL – 13RAP/10RAP: Universal Rigid Style Ocular

DIOPTER POSITION MARKS (WHITE) Must be aligned to ensure proper focus for photography and use with an assistant’s observerscope.

IMMERSIBLE MARKING The blue line here indicates the scope is fully immersible. DIOPTER ADJUSTMENT RING Adjustable for individual’s eyesight.

UMBILICAL CABLE

D U

INSTRUMENT CHANNEL INLET For introduction of biopsy forceps and other accessories.

DEFLECTION CONTROL LEVER Deflects the distal end.

EYEPEACE

OCULAR LENS

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NASO-PHARYNGO-LARYNGOSCOPES

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!

RUBBER INLET SEAL (MODEL: OF-B70) Allows passage of accessories while preventing escape of fluids and air. VENTING CONNECTOR Accepts “RED” ETO sterilization venting cap. Also accepts leakage tester.

LIGHT GUIDE The standard PENTAX sleeve Model OF-G1 is already attached to these instruments. Various adapter sleeves for other manufacturer’s light sources are also available. (See page 10)

BENDING SECTION

N TUBE INSERTIO

DISTAL END

OBJECTIVE LENS

INSTRUMENT CHANNEL

LIGHT GUIDE

WARNING: Immediately after use, the metal light guide prong 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.

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1-2. ACCESSORIES (FNL-15RP3/13RAP/10RAP) 1) Biopsy Forceps ENHANCED FLEXIBLE PORTION

GRIP FLEXIBLE SHAFT

CUPS

HANDLE

2) Cleaning Brush WHITE BRISTLE

FLEXIBLE SHAFT

HANDLE

3) Suction Cylinder Cleaning Brush CS-C2S for FNL-15RP2 CS-C3S for FNL-15RP3

CAUTION: Because of the effect that accessories used through the instrument channel of the fiberscope can have on the performance of the fiberscope itself, it is strongly recommended that only PENTAX accessories be used with PENTAX fiberscopes. 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 fiberscope.

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

NOTE: 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 may be approximately 30 cm longer than the endoscope working length.

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NASO-PHARYNGO-LARYNGOSCOPES

1-3. LIGHT SOURCE CAUTION: Please refer to the instructions supplied with the light source. Water bottle and air pump are not used with these scopes. Halogen Light Source LH-150PC BRIGHTNESS CONTROL KNOB Brightness of observing field can be adjusted.

X

TA

N

PE

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

POWER SWITCH Activates main power.

Halogen Light Source LH-150 II LAMP SELECTION SWITCH Allows user to switch over to spare lamp, should main lamp fail. SPARE LAMP INDICATOR When lit, this indicator means spare lamp should be replaced.

BRIGHTNESS CONTROL KNOB Brightness of observing field can be adjusted.

POWER SWITCH Activates main power.

LIGHT GUIDE SOCKET Other makers’ scopes can be accommodated to this socket by using proper adapter. (Illustration: OL-H3 adapter for PENTAX scope)

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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 LH-150/150II LH-150P/150PII

LX-500A LH-150FP

(OF-G1) LX-3000 LX-750P

Z142 Inspection of Light S eps

AL-ML(MACHIDA)

AL-AL(ACMI) AL-WL(WOLF) AL-SL(STORZ) AL-OL7/OL10(OLYMPUS ILK)

(OF-G1) AL-OL6 AL-OL11

PENTAX LIGHT SOURCE RECEPTACLE AL-OL6 : For Olympus Pre OES series light sources AL-OL11 : For Olympus CLK-4 and all OES-10/20 series light sources

Please refer to the operating manual of the PENTAX light source involved for complete instructions. 1) 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. 2) The standard PENTAX adapter sleeve, OF-G1, included on PENTAX fiberscopes will allow connection to and light transmission from any PENTAX light source. 3) 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. For assistance, please contact your local PENTAX distributor or service facility. 4) Make sure the PENTAX light guide receptacle is properly aligned with the light guide index mark on the front panel of the light source. 5) Connect the endoscope light guide plug to the light source. 6) Turn on the light source to check for proper functioning.

NOTE: For a light source other than PENTAX, be sure that the correct adapter (AL-OL11, AL-OL6, etc.) is being used.

WARNING: The light emission from the endoscope could cause thermal injury. 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. The automatic brightness control mode of the Xenon light source should NOT be used with these scopes since there is no photosensor control circuitry within these instruments.

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NASO-PHARYNGO-LARYNGOSCOPES

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.

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CAUTION: If the endoscope is intended to be clinically used after testing of individual scope functions 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.

TE

ST D

19.6

0

GER

LEKAGE TESTER SHA-P2

AN

29.4 9.8 39.2

kPa

Leakage Tester

Before proceeding with inspection of individual functions, PENTAX Fiberscopes should be tested for the integrity of their water-tight design (example: hole in the bending rubber). 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 fiberscopes 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 any abnormalities or 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.

WARNING: All instruments must be reprocessed prior to first time use, after any repairs/service and before every 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.

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NASO-PHARYNGO-LARYNGOSCOPES

D U

2) Inspection of Deflection Control Slowly manipulate the deflection control lever to see that it functions smoothly. Be certain that a full and appropriate range of deflection is possible.

CAUTION: Any lack of smooth operation of the deflection control lever may be an indication of internal damage to the endoscope. To avoid the possibility of further damage to the endoscope or the possibility of malfunction during a procedure, do not use the endoscope if the angulation mechanism does not operate smoothly. When an endoscope exhibits excessive knob play, the instrument should not be used. 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. This is an indication that service is required to avoid more serious problems with the angulation control system, including control wire breakage and the potential for a “frozen” distal bending section.

UP–DOWN 130° – 130°

SUCTION TUBE

D U

DEPRESS

SUCTION NIPPLE

3) Inspection of Suction Mechanism (FNL-15RP3) a) Connect suction tubing from an external suction source to the suction nipple located on the control body. Place the distal tip of the endoscope in a basin of 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.

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.

CAUTION: A rubber inlet seal in good conditon must be attached to each instrument channel inlet to prevent loss of suction and a risk of cross contamination to the end user due to the potential for reflux (spit-back) of patient fluids. These rubber seals are semi-disposable and should, therefore, be checked before use and replaced as needed. Worn and/or damaged seals may result in leakage and should be replaced.

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CLOSE OPEN

4) Inspection of Biopsy Forceps and Instrument Channel (FNL-15RP3/13RAP/10RAP) 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.

WARNING: Never perform the electro-surgery with this scope.

CAUTION: The instrument channel is made of stainless steel 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.

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NASO-PHARYNGO-LARYNGOSCOPES

2-3. PREPARATION JUST BEFORE INSERTION OF FIBERSCOPE

WARNING: Every fiberscope should be properly disinfected or sterilized before being used for the first time. Every fiberscope should have been properly cleaned, disinfected, or sterilized after any previous use and after being returned for any repairs/ service.

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. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each clinical use.

D

1) Check the optical image of the endoscope. 2) If necessary, gently clean the objective lens with a cotton-tip applicator moistened with alcohol. A lens cleaner (anti-fogging agent) may also be applied via gauze or other applicator. 3) The individual user should adjust the diopter adjustment ring to make sure that a clear view can be obtained. No further adjustment should be necessary during a procedure. 4) Place a bite block on the insertion tube to protect the insertion tube after the scope is introduced if the scope is to be introduced transorally. 5) Apply a medical grade water soluble lubricant to the insertion tube. Do not use petroleum based lubricants.

U

LUBRICANT

NOTE: The objective lens must be kept free of the lubricant and excess lens cleaner.

WARNING: Never drop this equipment or subject it to severe impact as it could compromise the functionality and/or safety of the unit. Should this equipment to be mishandled or dropped, do not use it. Return it to an authorized PENTAX service facility for inspection or repair.

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3. DIRECTIONS FOR USE WARNING: This instrument should only be used by physicians who have thoroughly studied all the characteristics of this instrument and who are familiar with the proper techniques of endoscopy. During the procedure, always wear protective garments such as gloves, gowns and face masks, etc. to minimize the risk of cross contamination.

3-1. PRETREATMENT 1) The patient should be prepared in your normal endoscopy regimen.

3-2. INSERTION AND WITHDRAWAL BITE BLOCK D

U

1) Slowly insert the scope under direct vision. If the scope is introduced transorally when the distal end of the scope is passed through the pharynx, the patient should be gently biting down on the optionally available bite block to maintain the bite block’s position during the procedure. 2) Adjust the intensity of the light source to obtain a brightness level suitable for observation.

WARNING: The light emission from the endoscope could cause thermal injury. To minimize the risk, use only the minimum amount of brightness and avoid close stationary viewing and unnecessary prolonged use.

NOTE: The automatic brightness control mode of the LX-750P should NOT be used with these NasoPharyngo-Laryngoscopes since there is no photosensor control circuitry within these instruments. The risk of thermal injury exists because in the absence of this electrical system, the LX-750P when in the automatic brightness mode, will transmit maximum illumination.

3) The deflection control should be used as needed to position the scope. The deflection of the tip should be done under direct vision in a gentle and deliberate manner. 4) If secretions or other debris are present making observation difficult, suctioning should be performed. (Model FNL-15RP3) 5) Photography may be carried out as necessary. 6) Always withdraw the scope under direct visualization.

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NASO-PHARYNGO-LARYNGOSCOPES

WARNING:

D U

If for any reason, the image is lost due to power shortage, lamp or light source failure etc., the scope tip should be straightened to its neutral position, and the insertion tube should be carefully and slowly withdrawn from the patient.

3-3. BIOPSY (FNL-15RP3/13RAP/10RAP)

CAUTION: For ALL types of endoscopic accessory instruments, always maintain a view of the accessory during advancement, use and withdrawal of the device.

1) Insert the forceps through the slit in the rubber inlet seal. Be certain to hold the forceps handle in such a way to ensure that the jaws of the forceps are in a fully closed position during insertion. m 5c

NOTE: When the cups are first passed through the inlet seal, a temporary resistance will be encountered. Hold the shaft tightly at about 5 cm from the cups and push it through.

NOTE: During insertion, if the forceps are found hard to advance further due to resistance, decrease the deflection of the bending section to a level suitable for smooth insertion and insert the forceps again.

CAUTION: Never apply excessive pressure when introducing any accessory since the instrument channel may be damaged. Malfunction of the scope as well as costly repairs may result.

2) When a portion of the cups of the forceps becomes visible in the viewing field, carefully advance the forceps onto the target area. 3) Open the forceps cups and advance the forceps against the target area. Carefully squeeze the forceps handle to close the cups and obtain a specimen within the cups. Always maintain a view of the accessory during advancement. 4) Withdraw the forceps slowly with the cups closed.

NOTE: Because of the effect accessories used in the instrument channel of the fiberscope can have on the performance of the fiberscope itself, it is strongly recommended that PENTAX accessories be used with PENTAX fiberscopes. 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 fiberscope. ´

WARNING: Never perform electro-surgery with these scopes.

NOTE: Maximum outer diameter of an endoscopic accessory instrument must be at least 0,2 mm less than the specified instrument channel diameter in Penatx endoscopes. Working length of an endoscopic accessory instrument may be approximately 30 cm longer than the endoscope working length. - 17 -

4. CARE AFTER USE IMPORTANT INSTRUCTIONS Cleaning-Disinfection-Sterilization: PENTAX Endoscopes To maintain maximum performance and a long service life of the Fiberscope, proper care after each procedure is extremely important. Immediately after the completion of a procedure, the Fiberscope should be thoroughly and carefully cleaned. If the Fiberscope is left uncleaned for some time after use, dried blood, mucous or other debris may cause damage to the instrument or may interfere with the ability of the user to properly reprocess the endoscope.

NOTE: This owner’s manual contains detailed recommendations on the manual reprocessing of PENTAX endoscopes using PENTAX supplied cleaning/disinfecting adapters. Automated endoscope reprocessors (AER) may provide a means of reprocessing flexible endoscopes, including PENTAX instruments. However, all reprocessing claims, instructions, validation studies, compliance with local regulations and/or guidelines are the responsibility of the manufacturer of the AER. Any questions regarding the use of AERs with PENTAX endoscopes should be directed to the AER manufacturer.

WARNING: The importance of meticulous mechanical cleaning of the endoscope cannot be overemphasized. Prior to disinfection or sterilization all instruments must be scrupulously cleaned. Failure to do so could result in incomplete or ineffective disinfection and sterilization. During the reprocessing process, always wear protective garments such as gloves, gowns and face masks, etc. to minimize the risk of cross contamination.

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