FL-100 Intubating Fiberscope Owners Manual

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TABLE OF CONTENTS Conventions ...

2

General Precautions ...

2

Symbols ...

2

Components ...

3

Nomenclature and Function ...

4

Fiberscope ...

4

Light Source ...

5

Accessories ...

6

Photographic Equipment ...

6

Preparation and Inspection for Use ...

7

Inspection of Light Source ...

7

Inspection of Fiberscope...

8

Preparation Prior to Insertion of Fiberscope... 10 Operation ... 11 Pretreatment ... 11 Insertion and Withdrawal ... 11 Care after Use ... 12 Important Instructions ... 12 Care after Each Procedure... 12 Pre-cleaning at the Examination Room ... 12 Cleaning at the Work Room ... 13 Enzymatic Cleaning Solution ... 15 Cleaning of Accessories ... 16 Schematics ... 17 Internal Schematics of a Welch Allyn Endoscope ... 17 Internal Schematic of the Welch Allyn FL-100 Intubating Fiberscope ... 18 Internal Schematic Showing Complete Cleaning/Disinfecting System... 18 Disinfection and Sterilization... 19 High-level Disinfection ... 19 Compatible Disinfecting Solutions ... 21 Disinfection of Accessories ... 21 Sterilization and Aeration ... 22 Care During Storage ... 24 Servicing ... 25 Care and Maintenance Tips ... 25 Leakage Tester Instructions... 27 Dry Test, Stage I ... 27 Wet Test, Stage II ... 28 Specifications ... 29

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CONVENTIONS GENERAL PRECAUTIONS The user of the FL-100 instrument should be thoroughly trained in the techniques of upper airway endoscopy. This instrument is specifically designed to assist endotracheal intubation as well as diagnosis in the Upper Airway. Do not use the FL-100 for any purpose other than that for which it is designed. This manual describes the procedures for inspecting and preparing the instrument for use. It does not describe the performance of an endoscopic procedure or any of the medical aspects of endotracheal intubation. This instrument should only be used by physicians or practitioners trained in its use. Failure to read and understand the material contained in this manual could result in patient injury. Also, failure to follow the instructions provided herein could result in malfunction and/or damage to the instrument. This manual contains instructions on the maintenance and reprocessing of the FL-100. Every effort has been made to ensure that the listed disinfecting and sterilizing solutions and/or processes are compatible with this instrument and are effective. Since infection control practices are constantly changing, Welch Allyn recommends that the user remain aware of the latest practices and any federal, local, or hospital regulations pertaining to this very important issue.

SYMBOLS

WARNING: Indicates a potentially hazardous situation which, it not avoided, could result in death or serious injury.

CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or property damage.

NOTE: Indicates a potentially hazardous situation which, if not avoided, may result in property damage. Also, advises owner/operator about important information on the use of this equipment.

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

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COMPONENTS

Welch Allyn

RL-100 LENS CLEANER

Description

Components/Qty.

Accessories/Qty.

Fiberscope

65300

Light Adaptor

650031-3 Welch Allyn ACMI Adaptor (1)

Cap

650008

Eyepiece Cap (1)

Vent Cap

650028

ETO Vent Cap & Tag (1)

65012 each

Cleaner

650007

Lens Cleaner (1)

65304 each

Valve

653014

Rubber Suction Control Valves (3)

65304 each

Seal

310183

Rubber Inlet Seals (10)

31039 (5)

Brushes

653012 653011 653010

Long Short Suction Cylinder

65302 Brush Set (Long, short and suction cylinder)

Cap

653013

Suction Cylinder Closure Cap (1)

65303 each

FL-100 Intubating Fiberscope (1)

65017 WA ACMI 65004 Olympus CLK-3 65005 Olympus CLK-4 65010 Olympus ILK-3 65011 Machida 65014 Pentax 65016 Wolf 65018 Storz

49500 Welch Allyn Light Source

65009 Leakage Tester

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NOMENCLATURE AND FUNCTION FIBERSCOPE Diopter Adjustment Ring Accommodates differences in eyesight Immersible Mark Green line indicates that it is totally immersible

Eyepiece Ocular Lens Anti-reflection multi-layer coated optics for clean, sharp image

Diopter Position Marks (White) Marks must align to ensure proper focus for assistant’s observerscope or camera

Deflection Control Lever Deflects the distal end of insertion tube 130° up or down Suction Control Valve Allows for aspiration through the accessory/suction channel

Suction Nipple Allows for attachment to external suction device Rubber Inlet Seal Allows accessories to be passed through, while preventing fluids and air to escape Accessory/Suction Channel Inlet Allows biopsy forceps and other accessories to be introduced Umbilical Cable

Insertion Tube Diameter: 3.5 mm Working length: 600 mm

Distal End Accessory/ Suction Channel Light Guides

ETO Vent Cap (Red) Vents endoscope interior to equalize internal and external pressure Note: See sterilization section for use

Objective Lens Venting Connector Seats ETO vent cap and leakage tester

Bending Section

4

Light Guide The Welch Allyn sleeve part number 650031-3 is standard and comes attached to instrument. Other adaptor sleeves for other manufacturer’s light sources are also available (see page 3).

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LIGHT SOURCE

Power Switch

Fan Grill

Fuse Drawer AC Power Input

Light Control Knob

FRONT

Lamp Access Knob

BACK

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ACCESSORIES WELCH ALLYN LIGHT SOURCE (49500) CLEANING BRUSHES White Bristle

Flexible Shaft

Proximal End

Long (653012)

Short (653011)

Suction Cylinder (653010)

CAUTION: It is strongly recommended that only Welch Allyn accessories be used with the Welch Allyn FL-100 Intubating Fiberscope. Other accessories may adversely affect the performance of the fiberscope. If a unique or highly specialized accessory from another source is required, please contact Welch Allyn to arrange a test of its compatibility before using it with the Welch Allyn FL-100 Intubating Fiberscope.

PHOTOGRAPHIC EQUIPMENT The Welch Allyn FL-100 Intubating Fiberscope is equipped with a universal eyepiece that will accommodate most camera adaptors.

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

INSPECTION OF LIGHT SOURCE Please refer to the operating manual of your Welch Allyn Light Source for complete instructions.

CAUTION: Verify that the supply voltage matches the voltage range indicated on the rear of the Welch Allyn Light Source. To prevent temporary blinding, turn power on only after the fiber optic bundle is plugged in and the intensity control knob is set to the minimum position. The fiber optic bundle port is hot when fiber optic bundle is removed.

1. With the power switch in OFF position, plug light source into a properly grounded hospital grade receptacle. Welch Allyn light sources are equipped with a hospital grade plug and grounding conductor. 2. The standard Welch Allyn adaptor sleeve included on FL-100 allows connection to and light transmission from any Welch Allyn Iight source. 3. Depending upon the manufacturer, model and/or type of light source to be used, an adaptor may be needed to make a complete connection between the source of illumination and the Welch Allyn FL-100 fiberscope. This depends on the manufacturer, model and/or type of light source. For assistance, please contact your local Welch Allyn distributor or service facility. 4. Connect the endoscope light guide plug to the light source. 5. Turn on the light source to check for proper functioning. NOTE: Be sure that the correct adaptor is being used for light sources other than Welch Allyn.

WARNING: The risk of thermal injury exists whenever fiber optic instruments are used with high intensity light sources. The risk of injury is greatest: • When a high intensity light source, such as the Welch Allyn HI•Lux lamp, is used. • During close stationary observation and/or prolonged close contact with mucosa. • 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.

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INSPECTION OF FIBERSCOPE Before proceeding, the Welch Allyn FL-100 fiberscope should be tested for water-tight integrity (example: tear in the accessory/suction channel). To perform this test, see the “Leakage Test Instructions” section (page 27).

1. INSPECTION OF THE INSERTION TUBE a) Check the entire surface of the insertion tube to assure that abnormal conditions such as bite marks, wrinkles and dents are not present. Any indentation in the flexible shaft of the fiberscope can cause damage to the fiber optics and internal mechanisms of the fiberscope.

Leakage Tester

b) Check the umbilical cable for outward signs of damage such as buckling, pinch marks, etc.

CAUTION: Do not use any fiberscope with outward signs of damage. An outwardly damaged fiberscope may cause malfunction during a procedure and further damage the scope.

c) Be sure the entire fiberscope is clean and has been subjected to either a high-level disinfection or sterilization process before each patient use. NOTE: The distal end of the fiberscope must be protected against damage from impact. Never apply excess force such as twisting or severe bending of the flexible portion of the fiberscope.

2. INSPECTION OF DEFLECTION CONTROL To assure smooth articulation, slowly manipulate the deflection control lever. Be sure that a full and appropriate range of deflection is possible.

CAUTION: If the deflection control lever is not operating smoothly, this may indicate internal damage to the fiberscope. To avoid the possibility of further damage or malfunction during a procedure, never use the fiberscope if the deflection control lever is not operating smoothly.

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3. SUCTION MECHANISM 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.

Suction Nipple Suction Tube

To Suction Source

Rubber Inlet Seal

Depress

b) Release the suction control valve to determine if the valve freely returns to its OFF position and the aspiration of water ceases. NOTE: A rubber inlet seal in good condition must be on the accessory channel inlet to prevent the loss of suction. Worn seals will result in leakage and should be replaced.

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PREPARATION PRIOR TO INSERTION OF FIBERSCOPE

WARNING: Every fiberscope should be properly disinfected or sterilized before each use. 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 needed, gently clean the objective lens with a cotton-tip applicator moistened with alcohol. A lens cleaner (anti-fogging agent) may also be applied with gauze or appropriate applicator.

Diopter Adjustment Ring

2. The 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.) 3. Use a bite block on the insertion tube to protect the insertion tube after the scope is introduced. 4. Apply a medical grade water soluble lubricant to the insertion tube. DO NOT use petroleum-based lubricants.

CAUTION: Never allow excessive lubricant or lens cleaner on the object lens.

Lubricant

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OPERATION WARNING: This instrument should only be used by qualified physicians who are thoroughly familiar with all the characteristics of this instrument and who are well-versed in the proper techniques of endoscopy.

PRETREATMENT 1. The patient should be prepared in the normal endoscopy regimen.

INSERTION AND WITHDRAWAL 1. Slowly insert the scope under direct vision. As the distal end of the scope passes through the pharynx, the patient should gently bite down on the 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. 3. The deflection control lever should be adjusted to properly position the scope. The deflection of the tip should be done under direct vision in a gentle and in a deliberate manner. 4. If bronchial secretions or other debris are present in the lungs making observation difficult, suctioning should be performed. 5. Photography can be carried out as necessary. 6. Always withdraw the scope under direct visualization.

WARNING: If for any reason the image is lost due to power shortage, lamp or light source failure, etc., straighten the scope tip to its neutral position, and then carefully and slowly withdraw the insertion tube from the patient.

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CARE AFTER USE IMPORTANT INSTRUCTIONS Cleaning-Disinfection-Sterilization: Welch Allyn Endoscopes Endoscopic instruments should be properly cleaned immediately after each use, to maintain maximum performance and a long service life for the fiberscope. If the fiberscope is left uncleaned for some time after use, dried blood, mucous or other debris may cause damage to the instrument and may interfere with the reprocessing ability of the instrument.

WARNING: The importance of meticulous cleaning of the endoscope cannot be over-emphasized. Prior to disinfection or sterilization, all instruments must be scrupulously cleaned. Failure to do so could result in incomplete or ineffective disinfection and sterilization.

CARE AFTER EACH PROCEDURE PRE-CLEANING AT THE EXAMINATION ROOM 1. Immediately after removing the fiberscope from the patient, gently wipe all debris from the insertion tube with a gauze moistened with an enzymatic cleaning solution. (See page 15 for a list of compatible detergents.) 2. Place the distal end of the fiberscope into detergent solution and aspirate through the channel for 5-10 seconds. Alternate aspiration of solution and air several times to create agitation for better pre-cleaning.

Aspirate

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CLEANING AT THE WORK ROOM 1. The fiberscope should be Leak Tested before proceeding with any further cleaning steps. NOTE: See section on Leakage Tester Instructions. The hand-operated Welch Allyn Leakage Tester is available as an optional accessory. 2. Prepare a basin with warm water and a mild enzymatic detergent.

CAUTION: BEFORE IMMERSING: Take OFF the “Red” ETO gas sterilization venting cap. The use of an enzymatic detergent immediately after each procedure to dissolve and remove organic contaminants and proteinaceous debris is essential to the care and maintenance of the endoscope from the standpoints of infection control and functionality.

3. Remove the rubber suction control valve and the rubber inlet seal. Then thoroughly (but gently) wash the entire surface of the endoscope and its components. Allow all items to soak in an enzymatic solution for the time period recommended by the manufacturer of the enzymatic detergent. Remove

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.

Remove Suction Control Valve

Remove Rubber Inlet Seal

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Suction Control Valve Receptacle (Cylinder)

4. A variety of special brushes are provided to clean the entire suction system. Brush clean the entire accessory/ suction channel: a) Use the short cleaning brush and insert the brush into the opening of the suction nipple. Gently pass the brush until it appears in the suction control valve receptacle. Repeat several times (see Figure 1). b) Next, insert the same short brush into the opening at the bottom of the suction control valve receptacle (cylinder) on the control head (see Figure 2) and gently advance until resistance is felt (approximately 12 cm). DO NOT USE EXCESS FORCE. Gently withdraw the brush. Repeat several times. NOTE: Be sure to inspect the bottom of the suction control valve receptacle on the control head for any debris. c) Insert the long brush into the accessory/suction channel inlet port and gently advance the brush until it exits the distal end of the scope. Clean debris off the brush and then gently withdraw the brush (see Figure 2). Repeat several times ensuring that only a clean brush is introduced into the channel each time.

Suction Nipple

(a)

Figure 1 (b) Suction Control Valve Receptacle (Cylinder)

Accessory/Suction Channel Inlet

(c)

Figure 2

Suction Cylinder

d) Using the specially designed suction cylinder cleaning brush, scrub clean the surfaces inside the suction control valve receptacle on the control head (See Figure 3). 5. Install the suction cylinder closure cap as illustrated. 6. With the rubber inlet seal in place, a large luer slip syringe can be attached to the end of the suction nipple and used to flush enzymatic detergent solution into the entire accessory/suction channel. Be sure the detergent solution is allowed to remain in contact with the internal channel surfaces for the recommended exposure time. The enzymatic detergent should dissolve and/or dislodge any debris that may be within these internal areas. 7. After the scope has been exposed to the detergent solution for an appropriate time, flush the accessory/ suction channel with air to purge remaining detergent.

Figure 3

Suction Cylinder Closure Cap

Figure 4

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

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8. Rinse the entire scope and all its components with clean water. 9. The entire accessory/suction channel should aIso be rinsed free of residual detergent using one of the following methods: a) With the suction cylinder closure cap still in place, fill a syringe with clean water and flush the accessory/suction channel. b) With the rubber inlet seal still in place, reinstall the rubber suction control valve and aspirate clean water through the entire channel of the scope.

WARNING: It is important that ALL internal channels, external scope surfaces and components be thoroughly rinsed with water to remove residuaI detergent solution. Accessory Suction Channel

10. Purge water from the accessory/suction channel and scope components. NOTE: 70% alcohol followed by compressed air, not greater than 24 PSI, may be used to facilitate drying. 11. Gently dry all external surfaces of the fiberscope with a soft gauze. Do not put tension on the insertion tube of the endoscope while drying, since the outer cover of the bending section may be excessively stretched. Dry the objective lens with a cotton tip applicator.

Objective Lens Light Guides Distal End

ENZYMATIC CLEANING SOLUTIONS* Specific reference to brand names is not an endorsement of their efficacy as a cleaning solution. Tests have shown these solutions to be compatible with Welch Allyn endoscopes, providing the manufacturer’s directions are adhered to. Brand Name

Source

Usage

Endozime Klenzyme Enzy-Clean Metrizyme Enzol

The Ruhof Corp. Calgon Vestal Labs Burnishine Products Metrex Research Corp. Johnson & Johnson Medical

Follow Manufacturer’s Instructions

NOTE: Other solutions should not be used until a sample has been submitted to Welch Allyn for compatibility testing. *These solutions must be enzymatic detergents or other cleaning agents specially formulated to clean flexible endoscopes.

WARNING: Prior to disinfection or sterilization, it is imperative that the scope and its components be thoroughly rinsed of any solutions previously used in the cleaning process. The scope and its components should be thoroughly dried. Failure to do so could result in ineffective or incomplete disinfection and sterilization.

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CLEANING OF ACCESSORIES 1. Accessories need to be cleaned immediately after each use, since dried blood, mucous or other debris may cause damage to the instrument and interfere with the ability of the user to reprocess the device. 2. Place the accessories in a basin of warm water and a mild enzymatic detergent. Allow these to soak for the time period recommended by manufacturer. 3. Clean by gently wiping with a soft gauze. 4. Rinse all residual detergent from the accessory by immersing it under clean water. NOTE: All detergent must be removed from all the accessories. Any detergent that remains after the water evaporates can interfere in the subsequent sterilization process.

CAUTION: DO NOT use ultrasonic cleaning methods on the fiberscope itself.

5. Ultrasonic cleaning of accessories is recommended, provided the manufacturer’s instructions and the parameters below are followed: Frequency Range Optimum Frequency Time

31-45 kHz 10 kHz 5-10 minutes

NOTE: DO NOT use caustic or abrasive solutions in the ultrasonic cleaner.

6. After cleaning and thoroughly rinsing, the accessories should be gently dried using a soft gauze. NOTE: Other reusable accessories (channel cleaning adaptors, cleaning brushes, bite block, etc.) and scope components (rubber inlet seals and rubber suction control valves, etc.) may be cleaned in a similar manner as above. Ultrasonic cleaning methods are recommended for accessories and scope components whose entire surfaces are not easily accessible by manual cleaning.

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SCHEMATICS INTERNAL SCHEMATICS OF A WELCH ALLYN ENDOSCOPE The following internal schematics have been provided to assist users in better understanding the intricate construction of Welch Allyn endoscopes. Knowledge of the various internal channels and tubes within an instrument and their relationship to each other helps facilitate the reprocessing of the endoscope. The FL-100 intubating fiberscope and its components have been specifically designed for efficient and effective reprocessing before each use by either a manual or automated method. Connectors on all Welch Allyn cleaning/disinfecting adaptors and scope inlet ports incorporate standard size luer-lock and/or luer-slip fittings to easily accommodate reprocessing devices or systems available from other manufacturers. The internal schematics show that the Welch Allyn cleaning system promotes efficient unidirectional flow of solutions. Starting from the suction nipple at the control body, solutions travel up to the valve cylinder, pass through the channel in the insertion tube and finally exit the channel opening at the distal tip of the scope. The elimination of multiple branching channels, combined with a direct pathway for solutions to travel, maximizes flow efficiency and ensures contact of disinfectant/sterilant with all internally exposed channel surfaces.

WARNING (USA): It is imperative that flexible endoscopes and other semi-critical devices be reprocessed using at least high-level disinfection with an EPA registered sterilant/ disinfectant. It should be noted that any endoscope automated reprocessing device or system* must be cleared for marketing by the FDA via the 510 (k) premarket notification or PMA approval process. Only reprocessing solutions/systems satisfying the above conditions and tested and found to be compatible by Welch Allyn should be used with Welch Allyn products. *Liquid chemical germicides (disinfectants/sterilants) to reprocess medical devices come under FDA regulation and new products must, therefore, undergo a 510 (k) premarket notification submission prior to introduction into interstate commerce.

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INTERNAL SCHEMATIC OF THE WELCH ALLYN FL-100 INTUBATING FIBERSCOPE Accessory/Suction Channel

Accessory/Suction Channel Inlet Suction Cylinder Control Valve

Suction Nipple

Umbilical Cord

To Suction Source

The illustration above shows the entire accessory/suction channel system in the Welch Allyn FL-100 Intubating Fiberscope. NOTE: All surface areas of the suction system must first be cleaned with an enzymatic detergent and then exposed to a high-level disinfectant or sterilant.

INTERNAL SCHEMATIC SHOWING COMPLETE CLEANING/DISINFECTING SYSTEM Accessory/Suction Channel

Accessory/Suction Channel Inlet Suction Cylinder Closure Cap

Suction Nipple

Luer-Slip Syringe with Cleaning/Disinfecting Solution

Umbilical Cord

To reprocess the Welch Allyn FL-100 Intubating Fiberscope, first an enzymatic detergent and then a high-level disinfectant or sterilant must be used. All internal lumens and all external instrument surfaces and scope components (inlet seal, suction control valve, etc.) need to be exposed to detergent and disinfectant/sterilant. Exposure times of detergent and disinfectant/sterilant must be strictly adhered to. NOTE: All solution entrance ports and flow pathways are illustrated above.

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DISINFECTION AND STERILIZATION HIGH-LEVEL DISINFECTION Before disinfecting the endoscope, it must be completely cleaned and dried (see “Care after Each Procedure” on page 12). The user is responsible for determining if the disinfecting techniques described here accomplish the desired clinical effect. Before complete immersion in any disinfecting solution, the endoscope needs to be “Leak Tested” (see page 27).

CAUTION: BEFORE IMMERSING: The “Red” ETO gas sterilization venting cap must be taken OFF.

1. Remove the rubber suction control valve. 2. Install the suction cylinder closure cap as illustrated. 3. a) The suction nipple, located on the control body, is designed with a standard luer slip fitting to accommodate a syringe or other standard device. Fresh disinfecting solution should be drawn into (or flushed through) the entire accessory/suction channel system. The rubber inlet seal should be in place during the flushing process.

WARNING: Avoid introduction of air during this process and confirm that no air bubbles exit the scope tip during flushing (or exit the suction nipple, if aspiration is used). The presence of air bubbles could prevent contact of the disinfectant with channel surfaces.

b) While the entire scope is immersed and the suction system is filled with disinfectant, the suction cylinder closure cap and the rubber inlet seal may be removed.

WARNING: It is imperative that ALL internal surfaces of the channels are in contact with the disinfecting solution for the time period recommended by the manufacturer of the solution.

NOTE: Please refer to the internal schematics on page 18.

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