FNL-10RBS NASO-PHARYNGO-LARYNGOSCOPE Owners Manual Feb 2012

IMPORTANT Intended Use These instruments are intended to provide optical visualization of the Upper Airway Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Ear, Nasal Passage, Trachea, and Bronchial Tree. The instruments are introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations. Never use the endoscope for any purpose other than that for which it has been designed.

Notes Read this manual before operating, and save this book for future reference. Failure to read and thoroughly understand the information presented in this manual, as well as those developed for ancillary endoscopic equipment and accessories, may result in serious injury including infection by cross contamination to the patient and/or user. Furthermore, failure to follow the instructions in this manual may result in damage to, and/or malfunction of, the equipment. This manual describes the recommended procedures for inspecting and preparing the equipment prior to its use and for the reprocessing and maintenance of the equipment after its use. It does not describe how an actual procedure is to be performed, nor does it attempt to teach the beginner the proper technique or any medical aspects regarding the use of the equipment. It is the responsibility of each medical facility to ensure that only well educated and appropriately trained personnel, who are competent and knowledgeable about the endoscopic equipment, antimicrobial agents/processes and hospital infection control protocol be involved in the use and the reprocessing of these medical devices. Known risks and/or potential injuries associated with flexible endoscopic procedures include, but are not limited to, the following: perforation, infection, hemorrhage, burns and electric shock. Current infection control guidelines require that Naso-Pharyngo-Laryngoscopes and other semi-critical medical devices, that normally come into contact with intact mucous membranes, such as in the Upper Airway, should at least be high-level disinfected before patient 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 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. If you have any questions regarding any of the information in this manual or concerns pertaining to the safety and/or use of this equipment, please contact your local PENTAX representative.

Sterility Statement The instruments identified in this manual 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.

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 manual, 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.

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.

TABLE OF CONTENTS 1.

2.

3.

4.

5.

NOMENCLATURE AND FUNCTION...

4

1-1. FIBERSCOPE...

4

1-2. LIGHT SOURCES...

6

PREPARATION AND INSPECTION FOR USE...

8

2-1. INSPECTION OF LIGHT SOURCE...

8

2-2. INSPECTION OF FIBERSCOPE...

8

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

12

DIRECTIONS FOR USE...

14

3-1. PRETREATMENT...

14

3-2. INSERTION AND WITHDRAWAL...

14

CARE AFTER USE...

16

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 HIGH-LEVEL DISINFECTION... 4-1-4 STERILIZATION AND AERATION...

17 17 18 20 22

MAINTENANCE...

24

5-1. POST REPROCESSING...

24

5-2. SERVICING...

24

5-3. CARE AND MAINTENANCE TIPS...

25

SPECIFICATIONS...

27

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1. NOMENCLATURE AND FUNCTION 1-1. FIBERSCOPE

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.

RUBBER STRAIN RELIEF

D U

DIOPTER ADJUSTMENT RING Adjustable for individual's eyesight

VENTING CONNECTOR Accepts “RED” ETO sterilization venting cap. Also accepts leakage tester. ANGULATION CONTROL LEVER Angulates the distal end.

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

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+

INSERTION PORTION

BENDING SECTION

DISTAL END

FNL-10RBS LIGHT GUIDE

OBJECTIVE LENS

ETO 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!

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LIGHT SOURCE SOCKET Accepts various devices including light source BS-LHAC, BS-LH1/2 or the light guide cable BS-LC1.

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1-2. LIGHT SOURCES CAUTION: - Do NOT touch the lamp and the lamp cover during and / or immediately after use to avoid burns. - Never place the light source or the light guide cable BS-LC1 in a steam autoclave nor subject them to ultrasonic cleaning methods. - Always turn off and unplug the light sources when not in use. - Never drop the light sources or subject it to severe impact as it could compromise the functionality and/or safety of the unit. Should the light source be mishandled or dropped, do not use it. - Mount the lamp cover securely to maintain its watertight integrity and to prevent creation of short-circuit. - Have an extra (spare) lamp.

WARNING: Avoid looking directly at the light exiting the light source.

1) MINIATURE HALOGEN LIGHT SOURCE BS-LHAC SERIES (TRANSFORMER TYPE) SWITCH Depress it to select. ON (I)/OFF(O). Green line appears when the power switch is turned OFF and disappears when the power switch is turned ON. RED DOT Is used to guide the light source into the scope socket in the endoscope. LAMP COVER (RED) Protects the lamp. Remove the lamp cover when replacing a lamp.

BS-LHACU (for 120V)

GREEN LINE BS-LHAC3/E (for 230V)

Designates lamp type.

CONNECTING COLLAR Securely mounts the light source to the endoscope.

BS-LHACB (for 230V)

ON

TRANSFORMER: Is NOT waterproof. EXCEPT FOR THE TRANSFORMER/PLUG, the entire light source and cord are immersible in solutions. Also it designates model name, serial number, etc.

PLUG Have the different plug configuration.

WARNING: Keep the transformer dry. Never touch it with wet hands or never allow liquids to splash on.

2) MINIATURE HALOGEN LIGHT SOURCE (BATTERY TYPE) BS-LH2

Hold this part stationary, when replacing a battery. RED DOT

BATTERY HOUSING CAP Turn counterclockwise to replace battery I

LAMP COVER (RED)

SWITCH Turn clockwise to I (ON) counterclockwise to O (OFF).

CONNECTING COLLAR

BS-LH2

Hold this part stationary, when replacing a battery.

LAMP COVER (GOLD)

BATTERY HOUSING CAP Turn counterclockwise to replace battery I

RED DOT

SWITCH Turn clockwise to I (ON) counterclockwise to O (OFF). CONNECTING COLLAR

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3) LED LIGHT SOURCE (BATTERY TYPE) BS-LL1

LED lamp turns on while this pin is depressed continuously by attaching this LED light source to the scope.

RED DOT This indicator is used to guide the light source into the scope socket in the endoscope.

POWER SWITCH Press to turn the unit ON/OFF.

Indication at Power ON The LED lights green when switched ON Battery change precaution The LED lights yellow when the battery needs to be replaced.N

4) LIGHT GUIDE CABLE BS-LC1 (OPTIONAL ACCESSORY) Using the detachable Ligh Guide Cable, BS-LC1, other conventional light sources can be used. Please refer to the manual supplied with the light source. RED DOT FIBER OPTIC CABLE RED DOT

FIBER OPTIC CABLE (BS-LC1)

LIGHT GUIDE PLUG The standard PENTAX sleeve Model OF-G1 is already attached to the fiberoptic cable. Various adapter sleeves for other manufacturers’ light sources are also available. The BS-LC1 is immersible in solutions.

CONNECTING COLLAR

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WARNING: Immediately after use, the metal light guide prong of the light guide cable may be HOT. To avoid burns, do not touch the area immediately after use. For safer handling after a procedure, grasp the plastic light guide plug.

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

2-1. INSPECTION OF LIGHT SOURCE Please refer to the operating manual of the PENTAX light source involved for complete instructions.

2-2. INSPECTION OF FIBERSCOPE WARNING: All instruments must be reprocessed prior to first time use, after any repairs/service and before every patient use. When utilizing chemo-thermal processes for reprocessing PENTAX endoscopes, the instruments should be allowed to return to room temperature prior to use and/or further handling. 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 sterile or bacterial free 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.

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 nonPENTAX 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 scope’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 scope’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, 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 light guide cable (if the BS-LC1 is used) 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 a fiberscope with any abnormalities or outward signs of damage.

-8-

c) 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 scope 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. (1) Black adhesive band

(1)

(2)

(2) Black adhesive band (3) Close-up view

D U

(3)

(4) Bending Section

(4)

Figure 1

d) 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. All instruments must be reprocessed prior to first use, after any repairs/service and before every patient use.

67-42-15b EN

NOTE: • The distal end as well as the electrical contacts/pins on the PVE 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. • During pre-use inspection, ensure that the distal objective lens and the illumination 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 ethly or isopropyl alcohol.

-9-

2) Inspection of insertion tube flexibility a) Starting at the bending section junction, create a approximately 20 cm loop of the insertion tube as shown in the figure 2.

Figure 2

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. (Raise left hand and lower right hand)

Figure 3

(Raise right hand and lower left hand)

Figure 4

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.

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D U

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

Rubber strain relief

One method to check for looseness is to lightly grip the exposed part, and while grasping the component carefully attempt to move it in various directions. Use of a lintfree gauze while grasping metal parts is recommended as a protection for one’s fingers. If any part/component remains loose (after attempting to tighten) and/or if there is any indication or suspicion of an abnormality or outward signs of damage, do NOT use the endoscope. Contact your local PENTAX service facility.

CAUTION: To avoid damaging the endoscopes, do NOT twist, rotate or excessively bend any of the insertion tube strain reliefs (1) during inspection, clinical use, reprocessing, or any handling activity. Be particularly cautious for the insertion tube strain relief (1). When wiping the insertion portion, 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.

& 7

7

&

7

&

(1)

Do NOT Twist or Rotate

Do NOT Bend

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

PE NT FB-15 AX P

D U

(1) UP-DOWN 130°-130°

(1)

67-42-15b EN

Figure 5

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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.

2-3. PREPARATION JUST BEFORE INSERTION OF FIBERSCOPE WARNING: Every fiberscope should be properly cleaned, and disinfected or sterilized before being used for the first time. Every fiberscope should have been properly cleaned, and disinfected or sterilized after any previous use and after being returned for any repair/service.

WARNING: Current infection control guidelines require that endoscopes and their patient contact accessories either be sterilized or at 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.

1) If the endoscope has just recently been reprocessed, has been prepared or stored properly and passed all preprocedure inspections, the instrument should be ready to use. If necessary, the scope’s insertion tube may be wiped down with a gauze dampened with 70-90% medical grade ethyl or isopropyl alcohol. NOTE: Contact the manufacturer and follow local regulations regarding safe use, appropriate handling and disposal of cleaning and disinfection solution including alcohol. Material Safety Data Sheets (Health and Safety Data Sheets or similar documents depending upon country) available from the cleaning and disinfection solution (including alcohol) manufacturer should provide guidance to end users about composition, hazards, chemical and physical properties, first aid, handling and storage, stability, precautions, disposal, etc. associated with cleaning and disinfection solution including alcohol.

2) Check the optical image of the endoscope. 3) 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. 4) 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.

D

U AX NT 5P PEFB-1

Figure 6

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5) Apply a medical grade water soluble lubricant to the insertion tube. Do not use petroleum based lubricants. NOTE: The objective lens must be kept free of the lubricant and excess lens cleaner. (1) Lubricant

(1)

Figure 7

67-42-15b EN

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 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 1) Slowly insert the scope under direct vision.

D

U AX NT P PEFB-15

Figure 8

2) FOR THE CONVENTIONAL LIGHT SOURCES ONLY (using the BS-LC1). 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 Xenon light source should NOT be used with the scope since there is no photosensor control circuitry within the instrument. The risk of thermal injury exists whenever fiberoptic instruments are used with high intensity light sources.

3) The angulation control should be used as needed to position the scope. The angulation of the tip should be done under direct vision in a gentle and deliberate manner. Should resistance be encountered, never apply excessive force. 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 potential for malfunction of the angulation system, do NOT use the endoscope if the angulation mechanism does not operate properly. 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! If during a procedure angulation is lost in any direction such as when “cables snap” (broken pulley wire, broken angle wire, etc.), do NOT continue to use the instrument and do NOT rotate the angulation controls. Should the angulation system fail for any reason, stop the procedure, carefully withdraw the endoscope under direct visualization. The examples above are indications that service is required to avoid more serious problems with the angulation control system, including the possibility of a “frozen” distal bending section. A “frozen” bending section can make instrument extraction from a patient more difficult. - 14 -

4) FOR THE CONVENTIONAL LIGHT SOURCES ONLY (using the BS-LC1). Photography may be carried out as necessary. 5) Always withdraw the scope under direct visualization.

D U

WARNING: 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.

67-42-15b EN

Figure 9

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4. CARE AFTER USE IMPORTANT INSTRUCTIONS

Cleaning-Disinfection-Sterilization:

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 (AERs)/ WasherDisinfectors (WDs) may provide a means of reprocessing flexible endoscopes, including PENTAX instruments. However, only those Automated Endoscope Reprocessors (AERs)/Washer-Disinfectors (WDs) should be used whose manufacturers provide device-specific instructions and have validation data that support each AER/WD claim with respect to PENTAX model instruments. AER/WD manufacturers should be consulted for their specific claims including but not necessarily limited to • the ability of the AER/WD to provide a cleaned and high-level disinfected (or sterilized) endoscope and scope components (e.g., valves), • the identification of any special feature area (internal channel) or scope component that can not be reprocessed and therefore requires manual reprocessing, • the microbial quality of the rinse water, • the inclusion of an “automated” alcohol rinse cycle, • the inclusion of a terminal drying cycle that removes the majority of water/fluid within scope channels, • maintenance procedures for water filter replacement and/or decontamination of the filtration system to ensure the microbial claim of water, etc. • compliance with local regulations and/or guidelines. NOTE: This manual has been written having regard to ISO 17664 and national guidelines on reprocessing of medicalproducts (e.g. RKI, DGS/DHOS). CAUTION: (Automated Reprocessing) Unless the AER/WD has validated channel monitoring capability for device-specific scope models, • prior to "automated reprocessing" check and confirm the patency of any lumens/channels to ensure that • all internal channels are unblocked and/or unclogged • prior to use of any AER/WD confirm the integrity of all channel tubes and recommended channel cleaning adapters • once tubing sets are connected to the appropriate channels, check the tubing to confirm that there are no kinks or crimps that could restrict flow of solution throughout the endoscope • (if the unit allows) during reprocessing check and confirm that reprocessing solutions are exiting expected channel ports Failure to adhere to the above recommendations could result in inadequate cleaning, disinfection (or sterilization) of and/or improper removal of residues from all instrument channels/surfaces.

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4-1. CARE AFTER EACH PROCEDURE 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. CAUTION: To avoid damaging the endoscopes, do NOT twist, rotate or excessively bend any of the insertion tube strain reliefs (1) during inspection, clinical use, reprocessing, or any handling activity. Be particularly cautious for the insertion tube strain relief (1). When wiping the insertion portion, 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.

& 7

7

&

7

&

(1)

Do NOT Twist or Rotate

Do NOT Bend

4-1-1 PRE-CLEANING AT THE EXAMINATION ROOM CAUTION: Always turn off and unplug the light source after each procedure.

PE FB NT -15PAX

U

D

1) Immediately after removing the fiberscope from the patient, gently wipe all debris from the insertion tube with a gauze or the like moistened with a detergent solution.

Figure 10

WARNING: Keep the transformer dry. Never touch it with wet hands or never allow liquids to splash on it.

67-42-15b EN

WARNING: Immediately after use, the metal light guide prong of the light guide cable BS-LC1 may be HOT. To avoid burns, do not touch the area immediately after use. For safer handling after a procedure, grasp the plastic light guide plug.

- 17 -

WARNING: Do not touch the lamp cover during and/or immediately after use to avoid burns.

2) The endoscope with BS-LH1/LH2 or BS-LC1 attached to the light source socket can be immersed in solution. Before immersion, make sure the following. - BS-LH1/LH2 or BS-LC1 is securely attached to the endoscope. - BS-LH1/LH2 is turned off. - BS-LC1 is disconnected from the light source. - Battery housing cap of BS-LH1/LH2 is securely attached. 3) The endoscope with BS-LHAC attached to the light source socket can not be immersed, as the transformer is not immersible. Before immersion, remove BS-LHAC from the endoscope and attach the soaking cap BS-B1 to the light source socket.

BS-B1

Figure 11

4) Using soaking cap BS-B1, the endoscope without BS-LH1/LH2 or BS-LC1 can be also immersed in solution. Before immersion, remove BS-LH1/LH2 or BS-LC1 from the endoscope and attach the soaking cap BS-B1 to the light source socket. 4-1-2 CLEANING AT THE WORK ROOM 1) 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 nonPENTAX 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 scope’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 scope’s distal bending section.

2) Prepare a basin with warm water and a mild detergent. 3) Immerse the endoscope in detergent solution. Thoroughly (but gently) wash the entire surface of the endoscope. Make sure that the recessed areas are brushed clean, using the provided or similar effective cleaning brushes. Allow the endoscope to soak in a solution for a time period recommended by the manufacturer of the detergent.

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CAUTION: The solutions must be detergents or other cleaning agents specially formulated to clean flexible endoscopes. Follow the manufacturer’s instructions. For specific brands of compatible solutions, please contact your local PENTAX service facility or sales representative. CAUTION: BEFORE IMMERSING: • The “Red” ETO gas sterilization venting cap must be taken OFF. • The soaking cap BS-B1 or the miniature light source BS-LH1/LH2 or the light guide cable BS-LC1 should be securely on the light source socket of the endoscope. In the latter two cases, make sure the following - BS-LH1/LH2 is turned off - BS-LC1 is disconnected from the light source. - Battery housing cap of BS-LH1/LH2 is securely attached. (1) OFF

(1)

Figure 12

CAUTION: The use of a detergent immediately after each procedure to dissolve and remove organic contaminants and proteinacious debris is essential to the care and maintenance of the endoscope from the standpoints of infection control and functionality.

4) Immerse the endoscope in detergent solution. Thoroughly (but gently) wash the entire surface of the endoscope. Make sure that the recessed areas are brushed clean, using the provided or similar effective cleaning brushes. Allow the endoscope to soak in a solution for a time period recommended by the manufacturer of the solution. NOTE: Do not squeeze or severely bend the insertion tube. Do not use any abrasive materials. Be careful to avoid damage to the distal lenses.

WARNING: The detergent solution should remain in contact with ALL external scope surfaces for the time period recommended by the manufacturer of the detergent.

WARNING: It is important that ALL, external scope surfaces be thoroughly rinsed with clean water to remove residual detergent solution.

67-42-15b EN

5) Using clean water, immerse the entire endoscope and thoroughly rinse it. 6) Gently dry all external sufaces of the endoscope with a soft gauze or the like. Do not put tension on the insertion tube on the endoscope while drying since the outer cover of the bending section may be excessively stretched. Dry the objective lens and the oculan lens with a cotton tip applicator.

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WARNING: Prior to disinfection or sterilization, it is imperative that any solutions previously used in the cleaning process be thoroughly rinsed and dried. Failure to do so, could result in ineffective or incomplete disinfection and sterilization. CAUTION: Never subject the endoscope to ultrasonic cleaning methods employing high-frequency ultrasound.

4-1-3 HIGH-LEVEL DISINFECTION Before any attempt is made to disinfect the endoscope, the complete cleaning procedure described elsewhere in this manual must have been completed. Prior to high-level disinfection, the end user should confirm the minimum effective concentration (MEC) of reused disinfectant, as per the manufacturer's instructions. WARNING: (in the USA or other countries adhering to FDA regulations) It is imperative that semi-critical devices including most flexible endoscopes should be reprocessed using at least high-level disinfection with a legally marketed liquid sterilant cleared as a high-level disinfectant. Only legally marketed automated endoscope reprocessing devices/systems whose device specific claims have been validated by the AER manufacturers, and cleared anti-microbial agents that have been tested by PENTAX and found to be compatible with materials used in PENTAX instruments should be used to reprocess PENTAX products. Endoscopes are semi-critical devices that require at least high-level disinfection. Only use legally marketed solutions and/ or automatic endoscope reprocessing machines or washing disinfection machines whose manufacturers have made validation testing with PENTAX products (specific to PENTAX endoscope model number). A listing of legally marketed solutions/systems which have been determined to be compatible with PENTAX brand products is available from your local PENTAX dealer/authorized service provider. Be aware of the important note regarding infection control on the inside cover of this manual.

Before complete immersion in any disinfecting solution, 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: BEFORE IMMERSING: • The ‘Red’ ETO gas venting cap must be taken OFF. • The soaking cap BS-B1 or the miniature light source BS-LH1/LH2 or the light guide cable BS-LC1 should be securely on the light source socket of the endoscope. In the latter two cases, make sure the following. - BS-LH1/LH2 is turned off - BS-LC1 is disconnected from the light source. - Battery housing cap of BS-LH1/LH2 is securely attached.

(1) OFF

(1)

Figure 13

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