WANM-3488-COL 4/19/99 9:27 AM Page c2 Thank you for purchasing the Welch Allyn FL-100 Intubating Fiberscope and Light Source. The operating and maintenance instructions found in this manual should be followed to ensure many years of reliable service. Please read these instructions thoroughly before attempting to use your new instrument.
WANM-3488-COL 4/19/99 9:27 AM Page 1 TABLE OF CONTENTS Conventions ...................................................................................................................... 2 General Precautions ........................................................................................................ 2 Symbols .............................................................................................................................. 2 Components .......................................
WANM-3488-COL 4/19/99 9:27 AM Page 2 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.
WANM-3488-COL 4/19/99 9:27 AM Page 3 COMPONENTS Welch Allyn RL-100 LENS CLEANER Description Components/Qty. Accessories/Qty.
WANM-3488-COL 4/19/99 9:27 AM Page 4 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 A
WANM-3488-COL 4/19/99 9:27 AM Page 5 LIGHT SOURCE Power Switch Fan Grill Fuse Drawer AC Power Input Light Control Knob FRONT Lamp Access Knob BACK 5
WANM-3488-COL 4/19/99 9:27 AM Page 6 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.
WANM-3488-COL 4/19/99 9:27 AM Page 7 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.
WANM-3488-COL 4/19/99 9:27 AM Page 8 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.
WANM-3488-COL 4/19/99 9:27 AM Page 9 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.
WANM-3488-COL 4/19/99 9:27 AM Page 10 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.
WANM-3488-COL 4/19/99 9:27 AM Page 11 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.
WANM-3488-COL 4/19/99 9:27 AM Page 12 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.
WANM-3488-COL 4/19/99 9:27 AM Page 13 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.
WANM-3488-COL 4/19/99 9:27 AM Page 14 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).
WANM-3488-COL 4/19/99 9:27 AM Page 15 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.
WANM-3488-COL 4/19/99 9:27 AM Page 16 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.
WANM-3488-COL 4/19/99 9:27 AM Page 17 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.
WANM-3488-COL 4/19/99 9:27 AM Page 18 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.
WANM-3488-COL 4/19/99 9:27 AM Page 19 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).
WANM-3488-COL 4/19/99 9:27 AM Page 20 4. While the entire instrument is immersed in disinfecting solution, the syringe used in previous steps can be removed. The entire instrument, however, should remain fully immersed in the disinfecting solution. 5. The endoscope’s component parts should remain in contact with the disinfecting solution for the time period recommended by the manufacturer of the solution. Make sure it is left in long enough to accomplish the desired clinical effect. 6.
WANM-3488-COL 4/19/99 9:27 AM Page 21 COMPATIBLE DISINFECTING SOLUTIONS Specific reference to brand names is not an endorsement of their efficacy as a disinfecting solution. Tests have shown these solutions to be compatible with Welch Allyn endoscopes, providing the manufacturer’s directions are adhered to. Solution Glutaraldehyde Aldehyde Brand Name Source Cidex (14 day) Johnson & Johnson Medical Inc. Wavicide-01 Wave Energy System Inc. Metricide (14 day) Metrex Research Corp.
WANM-3488-COL 4/19/99 9:27 AM Page 22 STERILIZATION AND AERATION Before sterilizing the fiberscope, it must be completely cleaned and dried (see “Care after Each Procedure”, page 12). The user is responsible for determining if the sterilizing techniques described here accomplish the desired clinical effect.
WANM-3488-COL 4/19/99 9:27 AM Page 23 2. IMPORTANT: Prior to placing the FL-100 Intubating Fiberscope in a gas sterilizer or aeration chamber: a) The “Red” ETO Gas Sterilization Venting Cap MUST be “ON” securely. NOTE: This is opposite of the immersion instructions. b) Temperature must not exceed 55°C (131°F). c) Pressure must not exceed 24 PSI. d) Humidity must not exceed 50%. ETO Gas Sterilization Cap e) Sterilization procedure must not exceed 4 hours. 3.
WANM-3488-COL 4/19/99 9:28 AM Page 24 C) OTHER METHODS OF STERILIZATION In addition to ETO and “Cold Sterilization” techniques, Welch Allyn endoscopes have been found to be compatible** with the Steris Sterilization® System/Process. **Based upon current data, repeated use of the Steris System could cause fading of the black anodized metallic components of Welch Allyn endoscopes.
WANM-3488-COL 4/19/99 9:28 AM Page 25 SERVICING Before returning any instrument for repair to Welch Allyn, the instrument should first undergo appropriate reprocessing/decontamination procedures for the purpose of infection control. 1. All instruments requiring repair should be shipped in the original carrying case with appropriate packing, along with comments describing the instrument damage and complaint. 2.
WANM-3488-COL 4/19/99 9:28 AM Page 26 • Do NOT reuse disposable accessories intended for single patient or one-time use. • Do NOT expose the endoscope or accessories to harsh chemical solutions. Strictly adhere to exposure times recommended by the manufacturers of compatible solutions. • Avoid contact of any flexible portion of the endoscope with any sharp-edged objects (bed frames, table top corners, sink drains, accessories hanging in storage cabinets, etc.
WANM-3488-COL 4/19/99 9:28 AM Page 27 LEAKAGE TESTER INSTRUCTIONS The leakage test is a simple two (2) stage test of the watertight integrity of the instrument. Air pressure is introduced into the interior of the instrument via a hand pump. The FL-100 scope is then checked for pressure decay by using a pressure gauge. A secondary visual check is also performed.
WANM-3488-COL 4/19/99 9:28 AM Page 28 WET TEST, STAGE II After determining that there are no major leaks in Stage I testing, Welch Allyn endoscopes may be immersed in clean water to test for loss of integrity in the watertight construction. 1. With the Leakage Tester securely attached to the scope and the scope pressurized with the gauge indicator in the GREEN zone, the entire scope may be immersed in clean water (Figure #5).
WANM-3488-COL 4/19/99 9:28 AM Page 29 SPECIFICATIONS Angle of View Depth of Field Diopter Tip Deflection Rigid Distal Diameter Insertion Tube Diameter Diameter of Accessory/Suction Channel Insertion Tube Working Length Total Length 90° 3-50 mm +2 to -8 dptr. Up 130°, down 130° 3.4 mm 3.5 mm 1.4 mm 600 mm 800 mm NOTE: Specifications are subject to change without notice. DISTAL END Up 130° 3.5 mm Accessory/Suction Channel Light Guide 0° Objective Lens 1.
Medical Division 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 (800) 535-6663 FAX (315) 685-3361 Printed in U.S.A. Part No. 653001 Rev.