FX-100 Flexible Sigmoidoscope Operating Instructions

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Welch Allyn Thank you for purchasing the Welch Allyn FX-100 Flexible Sigmoidoscope. The operating and maintenance instructions found in this manual should be followed to ensure many years of accurate and reliable service. Please read these instructions thoroughly before attempting to use your new FX-100 Flexible Sigmoidoscope.

Contents

Page No.

Specifications ... 3 Components.. ... 4 Nomenclature ... 7 Prior to Initial Use ... 9 System Setup ... 10 System Inspection ... 11 Operations ... 17 Electrosurgery y ... 22 Cleaning and Disinfection ... 22 Cleaning.. ... 24 Disinfection ... 35 Sterilization ... 47 Troubleshooting Chart ... 48 Maintenance and Storage ... 50 Service ... 51

Warning The user of the FX-100 Flexible Sigmoidoscope should be thoroughly trained in the medical procedures appropriate to the equipment. Furthermore, time should be taken to read and understand these instructions before performing any procedures. Instructions for other equipment used in conjunction with the flexible sigmoidoscope (e.g. electrosurgical generators, suction machines, snares, etc.) should also be read and understood. Failure to do so may result in injury to the patient and/or damage to the instrument. While this manual describes the recommended protocol for inspecting and operating the equipment, it does not outline procedure techniques. Only physicians trained and versed in the procedure of flexible sigmoidoscopy should use this equipment.

Specifications Description

Specification

Working Length

65 cm

Insertion Tube Diameter

13.6 mm

Biopsy Channel Diameter Bending Section Deflection Range

3.2 mm 180 oUp/Down 160o Right/Left

Angle of View

100o

Depth of Field

3-100 mm

Inflation

Automatic

Water Feed

Manual/Automatic

Immersible

Yes

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Components FX-100 Flexible Sigmoidoscope #33900 Fiber Optic Sigmoidoscope Includes:

FX-100 Fiber optic sigmoidoscope

#33922

#33910

Cleaning brushes (2 ea.)

#33906 #33911 All channel irrigator

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#33919 Air/water disinfection cap

#33930

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Biopsy seals (10 each)

#33907 Manual irrigation tubing

#33916

#33914

#I3391 8

#33913 Suction tubing

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#33924

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#33908

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2 Each - 30 cc syringe

#I33923 8 (Actual Sue)

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a

#33912 Biopsy cleanout adaptor

#33922 Leakage tester

#33906

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Dual lumen air/water line

#33916 Air/water disinfection line

#33914 Blowout adaptor

#33918 Valve lubricant

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#33924 Air/Water nozzle cleaning brush

#33923

(Actual Size)

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Air/water & suction valve "O" rings (12 per bag)

LX-150 Light Source #45250 Light Source includes: 1. Light source - LX-150 2. Water bottle assembly - #33905 3. FX-100 Disinfection Video Tape

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Water Bottle Assembly #33905

Adaptor #45157 CLK-3 Adaptor (Olympus) Allows the FX-100 to couple to an Olympus CLK-3 light source AW

CLK-3 Adapter Olympus CLK-3 Light Source

Welch Allyn Water Bottle

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Nomenclature Fiber Optic Sigmoidoscope CONTROL SECTION

Ground Cord Connector Objective Biopsy/Suction Lens Channel

ETO Vent Connector

Light Guides

Light Guide Terminal

Nozzle

ENDOSCOPE CONNECTOR TERMINAL

Nozzle

DISTAL TIP

BENDING SECTION

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Light Source

,

Control

Mater Bottle Connector Bracket Endoscope Connector Port

Air/ Water output

Lamp Access Door

Air Hose

BOTTOM VIEW

WATER BOTTLE 8

Prior to Initial Use Before preparation or set up of the equipment, check all components received against list of components (see components section) to verify complete set. If parts are missing, please notify Welch Allyn. Review the nomenclature, setup, operation and cleaning/disinfection sections to become familiar with the equipment. Specifically, inspect:

Fiber Optic Sigmoidoscope Insertion tube - for tears, cuts, dents, bubbles, bumps Control section - depress valves, test bending section deflection to assure smooth rotation of controls l Biopsy channel - pass cleaning brush through biopsy/suction channel to verify smooth passage l

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Light Source l

Cabinet - for any dents, scratches or other abnormalities

System Setup Light Source Plug the light source into a properly grounded 110-120 volt AC outlet. Activate power and air switches to verify functionality of illumination and pump. Fill water bottle approximately 3/4 full of clean tap water. Replace and tighten the cap and attach to water bottle bracket on the right side of light source. Connect air input hose on water bottle to air output connector on right side of light source.

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System Setup Fiber Optic Sigmoidoscope NOTE: Endoscope should be cleaned and disinfected prior to initial use, following the steps starting on page 24 and 35, or in the FX-100 cleaning and disinfection video tape. Plug endoscope connector terminal into endoscope connector port of light source. Push gently until it “snaps” into place.

Connect ends of dual lumen air/water line to the color coded air/water outputs on endoscope connector terminal (White = Water, Green = Air). Attach remaining end to water bottle. Mount 3/4 filled water bottle on light source bracket and couple remaining hose to air output connector.

3. Connect suction tube to suction port on control section. Attach remaining end to suction source receptacle.

4. Verify biopsy seal is seated in place over biopsy port opening.

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System Inspection The following steps should be repeated prior to every procedure to verify that the system is working. If any problem is encountered, immediately consult the troubleshooting section of this manual or contact your local Welch Allyn distributor or representative for assistance.

Physical Inspection: Insertion Tube and Bending Section Inspect the insertion tube for tears, cuts, dents, bubbles, bumps or other abnormalities on the surface. l Run your fingers carefully over the entire length to check for protruding braid, internal looseness or other abnormalities.

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CAUTION: Do not wind insertion tube into a tight radius. Serious damage to internal fibers could result. Proper storage procedures are outlined on page 50.

Deflection Controls Operate deflection controls slowly in all directions. Make sure that deflection is smooth and that no friction or grinding is present. Up/down plane - rotate the up/ down deflection control knob to its limit in each direction. It should rotate without excess friction.

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Right/left plane - rotate the right/left deflection control knob to its limit in each direction. Unlike the up/down control, a slight resistance or “drag” should be apparent. This is a design of the scope that allows the bending section to remain in position without holding the control knob. The bending section should not lock into position. To verify this, deflect the control to maximum and release. The bending section should return to a straight or neutral position by applying gentle pressure with your index finger.

WARNING: If the resistance in the right/left deflection plane is higher than normal, DO NOT USE the instrument. Contact Welch Allyn Customer Service for assistance. CAUTION: Do not deflect the bending section by hand. This applies excess force to the deflection mechanism and may result in failure.

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Light Source 1. Activate “power” switch. This will start the lamp and cooling fan. CAUTION: Do not look directly into the endoscope connector port when activating the light source. 2. The output of the light source is then controlled by the illumination intensity control. Clockwise rotation will increase illumination output. Counter clockwise will decrease illumination.

3. Activate “air” switch. This will start the internal insufflation pump.

Inspection of Air Feed 1. Place tip of bending section into clear water. Cover hole on top of air/water valve with finger tip. Do not depress valve. Air should flow freely through the instrument and water should bubble vigorously. 2. Remove finger - bubbling should end immediately.

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Inspection of Water Feed 1. Depress air/water valve completely. Water should flow in a constant stream over objective lens and light guides. 2. Release valve - water flow should end immediately.

NOTE: Upon initial setup, depress and hold down valve for a few seconds for water to completely fill line in instrument.

Inspection of Suction 1. Verify that suction tubing is attached and suction machine is on. 2. Immerse tip of bending section into clear water and completely depress suction valve. 3. Verify aspiration by viewing water flow into suction receptacle. Releasing valve should stop suction immediately.

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Inspection of Manual Water Feed 1. Connect manual irrigation tubing to auxiliary water inlet on endoscope.

2. Fill syringe with clean tap water and connect to remaining end.

3. Feed water through inlet and verify that it exits from water nozzle over objective lens and light guides.

NOTE: If leak occurs at inlet, tighten connector. If leak continues, call Welch Allyn Customer Service.

Inspection of Biopsy/Suction Channel 1. Deflect bending section 90o in “up” direction.

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2. Pass cleaning brush or forceps through the biopsy channel to verify a clear pathway. 3. Repeat Steps "1 and 2” in three remaining directions.

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NOTE: If resistance is encountered, DO NOT force. Contact Welch Allyn Customer Service.

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Inspection of Light Guides and Optics 1. With lamp on, hold distal tip approximately 40 mm from any printed surface.

2. Verify light is being emitted from light guides. 3. Hold eyepiece to your eye and rotate diopter ring until print is in focus. Verity focus from 10-40 mm from surface.

Inspection of Umbilical Cord 1. Check the umbilical cord for cracks, dents, crushed and twisted areas.

2. Verify that the endoscope connector terminal’s light guide terminal fitting is tight and does not move when moderate pressure is applied. NOTE: Instrument should be cleaned, disinfected and sterilized prior to every use. (Follow steps starting on pages 22 and 47, or demonstrated in the FX-100 cleaning and disinfection video tape).

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Operations Procedure The methods and techniques of flexible sigmoidoscopy are well defined and documented. Endoscopy training seminars and preceptorship programs are also in existence worldwide. No attempt is made in this manual to outline the medical procedure or techniques of flexible sigmoidoscopy. The physician should always take care to understand the clinical background of each patient and the possible contraindications of the procedure.

Holding the Instrument The control section is designed for the left hand. The "V" formed by the left thumb and index finger should be positioned beneath the area where the umbilical cord exits the control section. The suction and air/water valves are controlled by the index finger and middle finger respectively. The up/down deflection control is operated by the thumb. The right hand is used to advance and rotate (torque) the insertion tube. In some instances, it may be necessary to have an assistant hold the insertion tube while the right/left deflection control is rotated by the right hand.

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Insertion/Operation: Objective Lens Focusing Hold the distal tip 30-40 mm from a flat, printed surface. l Rest eyepiece on cheek bone of right eye. l Rotate the diopter ring until the characters are sharp and in focus.

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Insertion Prior to insertion, the bending section and distal portion of the insertion tube should be lubricated with a water soluble lubricant. DO NOT cover the light guides or objective lens. l DO NOT use lubricants that are petroleum based as these will deteriorate the rubber covering the bending section. l

NOTE: Patient preparation should be adequate so that no fecal material is present, If prep is poor, discontinue immediately. NOTE: If the image during insertion becomes red and out of focus (a “red out”), this is a sign that the tip is in contact with the mucosal wall. DO NOT ADVANCE FURTHER. Slowly withdraw the instrument and gently inflate the colon until lumen is visible.

Light Intensity Adjustment l

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Once lumen is visible, adjust the light intensity control to desired setting.

NOTE: The distal tip of the sigmoidoscope may become warm, if in continuous operation with illumination set too high, and may damage mucosa. Use the lowest light setting possible.

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Tip Deflection l

Slowly operate the deflection controls to guide the instrument through the lumen

CAUTION: If resistance is encountered, DO NOT force deflection controls. Doing so may damage the instrument and/or injure the patient. CAUTION: DO NOT advance the instrument if lumen is not visible. Blind advancement could result in perforation. WARNING: If during the procedure the deflection controls cease to function, terminate examination. Return both deflection controls to the neutral position, by rotating the deflection controls slowly until the “up” and “right” markings on the control knobs are in line with the eyepiece. Slowly withdraw the endoscope while viewing through the eyepiece. Do not operate controls.

Flushing Objective Lens Lubricant, mucous and fecal materials can cloud or fog the objective lens. The lens can be cleared by depressing the air/water valve. l If a more forceful wash is required, attach the manual irrigation tubing to the auxiliary water inlet and flush with a syringe filled with clean tap water. l Water drops retained on the lens can be removed by covering the hole on top of the air/water valve. l

Suction Fluid, secretions, and liquid stool can be aspirated by depressing the suction valve. l Aspiration will also remove excess air introduced during insufflation l

CAUTION: Care should be taken to avoid sucking mucosa into the channel. This phenomena can result in a “suction polyp” that can be mistaken for a lesion.

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Insufflation l

A collapsed lumen can be opened by insufflation. Cover air/water valve to inflate colon. Adequate insufflation can be maintained by insufflation and aspiration of air.

CAUTION: DO NOT overinflate the colon. This may cause severe patient discomfort as well as inhibit insertion.

Biopsy Passage Biopsy forceps and accessories should be inserted through the biopsy seal and into the channel. l The forcep should be advanced using short strokes, started by grasping the forcep sheath no more than 4 cm from the channel opening. l

WARNING: If resistance is encountered during passage through the bending section, relax deflection angle until passage is smooth and easy. Wetting the forcep with water or a medical grade silicon lubricant will promote easier passage. l

If biopsy seal “spits” or leaks while instrument is in place, remove defective seal and replace. NOTE: When replacing biopsy seal, rotate one full turn clockwise after pushing on luer-loc fitting to insure a proper seal. NOTE: Always flush biopsy channel immediately after a procedure by aspirating clear water through the channel (see cleaning). This will assist passage of instruments in subsequent procedures.

Obtaining a Biopsy l

Collect tissue sample by opening forcep and advancing open cups up against the mucosa. Close cups slowly until resistance is felt, and then hold. Gently pull back on forcep until small tissue sample is removed.

WARNING: DO NOT open forcep until biopsy cups are out of the biopsy channel and can be visualized. Doing so may damage biopsy channel. CAUTION: DO NOT exert excess force when closing forcep. Such action may damage forcep. 20