Olympus OSF-3 Instructions Manual
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Olympus OSF-3 Instructions Manual

Olympus OSF-3 Instructions Manual

Sigmoidofiberscope
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INSTRUCTIONS
SIGMOIDOFIBERSCOPE
OLYMPUS OSF-3
Refer to the endoscope's companion manual, the "OLYMPUS OSF-3 OPERATION MANUAL" for inspection
and operation information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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  • Page 1 INSTRUCTIONS SIGMOIDOFIBERSCOPE OLYMPUS OSF-3 Refer to the endoscope’s companion manual, the “OLYMPUS OSF-3 OPERATION MANUAL” for inspection and operation information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

  • Page 3: Table Of Contents

    Rinsing After High Level Disinfection..........Sterilization ..................Cleaning, Disinfection and Sterilization Procedures for Removable Parts and Cleaning Equipment ........Chapter 4 Washing and Disinfection Equipment ....Washing and Disinfection Equipment ..........Chapter 5 Storage and Disposal..........Storage ................... Disposal ..................OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 4 Contents OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 5: Symbols

    Symbols Symbols The meaning(s) of the symbol(s) shown on the back cover of this instruction manual are as follows: Manufacturer Authorized representative in the European Community OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 6: Chapter 1 General Policy

    • your institution’s reprocessing procedures • occupational health and safety regulations • national and local hospital guidelines and policies • the instructions in this manual • the mechanical aspects of endoscopic equipment • pertinent germicide labeling OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 7: Signal Words

    If the endoscope is not cleaned meticulously, effective disinfection (or sterilization) may not be possible. Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could hamper disinfection or sterilization efficiency. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 8 • Olympus confirms validation of the endoscope reprocessors recommended by Olympus only. If using endoscope reprocessor that are not recommended by Olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of reprocessing endoscope including all channels.
  • Page 9 For information on the durability against each method, please contact Olympus. If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, Olympus cannot guarantee the effectiveness, safety and durability of this instrument.

  • Page 10: Chapter 2 Compatible Reprocessing Methods And Chemical Agents

    Methods and Chemical Agents Compatibility Summary Olympus endoscopic equipment is compatible with several methods of reprocessing. Certain components and accessories, however, are not compatible with some methods, which can cause damage. For appropriate reprocessing methods, refer to Table 2.1 below, the recommendations of your infection control committee and national and local hospital guidelines and policies.
  • Page 11 Adapter (MB-107) Biopsy Valve (MB-358) ETO Cap (MB-156) applicable not applicable Table 2.1 Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 12: Detergent Solution

    Use a medical-grade low-foaming, neutral pH detergent or enzymatic detergent and follow the manufacturer’s dilution and temperature recommendations. Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. Do not reuse detergent solutions.

  • Page 13: Rinsing Water

    The ETO Cap must be attached to the Venting Connector on the Scope Connector prior to ETO gas sterilization. Figure 2.1 • Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 14 Exposure Time 1.75 hours ETO Gas Concentration 600 to 700 mg/l ° Aeration (Minimum) 12 hours in an aeration chamber at 50 to 57 C (122 to ° F) or 7 days at room temperature Table 2.2 OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 15: Steam Sterilization (Autoclaving) Of Accessories

    • Do not steam sterilize the endoscope. Steam sterilization (autoclaving) will severely damage the endoscope. • Effective sterilization will not be possible if items are packed tightly together in the autoclave; always pack items loosely. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 16 Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving. Temperature Exposure Time ° 132 to 134 Prevacuum 5 minutes ° (270 to 274 Table 2.4 OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 17: Chapter 3 Cleaning, Disinfection And Sterilization Procedures

    Do not wrap the endoscope’s Insertion Tube and Universal Cord into a coil with a diameter smaller than 40 cm. The endoscope can be damaged if coiled too tightly. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 18 • Rinsing Water • Large Basin for Rinsing • Soft brush • 70% ethyl or isopropyl Alcohol • Large Basin for Leakage Testing • Lint-free Cloth • Disinfectant Solution • 30 cm (30 ml) Syringe Figure 3.1 OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 19 Figure 3.2 Channel Cleaning Brush (BW-20T) The Channel Cleaning Brush is used to brush the inside of the suction channel and the holes in the Air/Water and Suction Valves (see Figure 3.3). Metal Tip Figure 3.3 OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 20 Figure 3.4 Channel-opening Cleaning Brush (MH-507) The Channel-opening Cleaning Brush is used to brush the outer surface of the Distal End of the endoscope, the Suction Cylinder and the Instrument Channel Opening (see Figure 3.5). Figure 3.5 OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 21 For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used. The cleaning brushes are consumable items. Should the slightest irregularity be suspected, use a spare instead. Using a defective brushes may cause equipment damage. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 22 Inspection of the Channel Cleaning Adapter Check for cracks, scratches, flaws, debris and other damage (see Figure 3.6). Inspection of the AW Channel Cleaning Adapter Check for cracks, scratches, flaws, debris and other damage (see Figure 3.7). OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 23: Cleaning, Disinfection And Sterilization Procedures

    Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 24: Precleaning

    Bending Section. Prepare the detergent solution in a 500 cm (500 ml) container. Wipe the entire Insertion Tube with a clean, lint-free cloth soaked in detergent solution. Begin wiping from the Boot toward the Distal End. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 25 AW Channel Cleaning Adapter (MB-107) to clean the Air/Water Channel after each use. Set the Airflow Switch on the Light Source to “OFF”. Remove the Air/Water Valve from the endoscope and place it in a container of detergent solution. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 26 30 seconds. Release the valve to feed air through the channels for 10 seconds or more (see Figure 3.10). Turn the Light Source OFF. Detach Air/Water Valve and attach AW Channel Cleaning Adapter. Figure 3.9 Alternately feed water and air. Figure 3.10 OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 27: Leakage Testing

    • Rotate the Leakage Tester connector cap until it stops. If it is not fully and properly attached, the endoscope’s interior will not be pressurized and accurate leakage testing will be impossible. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 28 This means that water will be able to penetrate inside the endoscope. If you locate a leak, remove the endoscope from the water and contact Olympus. When the Leakage Tester connector is in place, the covering of the Bending Section will expand as air pressure inside the endoscope increases.
  • Page 29 Disconnect the Leakage Tester from the Maintenance Unit or Light Source. Wait 30 seconds, or until the covering of the Bending Section contracts to its pre-expansion size. Disconnect the Leakage Tester connector cap from the venting connector. Thoroughly dry the Leakage Tester. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 30: Manual Cleaning

    With the endoscope immersed, use a soft brush or lint free cloth to thoroughly brush and wipe all outside surfaces of the endoscope. Pay particular attention to the Air/Water Nozzle opening and ensure that all surfaces of the Distal End are cleaned thoroughly (see Figure 3.12). OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 31 Depending on the staying location, the missing part may not be recoverable by passing a new brush or other endo-therapy accessories. In this case, contact Olympus. Withdraw the Channel Cleaning Brush from the Suction Channel gently, ensuring its shaft does not rub against the...
  • Page 32 Distal End of the endoscope. Clean off the bristles with your fingertips in the detergent solution. Carefully pull the brush back through the channel. Clean off the bristles in the detergent solution again. Repeat until all debris is removed. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 33 Pull the brush back and clean off the bristle in the detergent solution. Repeat until all debris is removed. Soak cleaning brushes (MH-507 and BW-20T) in detergent solution, then reprocess the brushes as described in Section 3.9, “Cleaning, Disinfection and Sterilization Procedures for Removable Parts and Cleaning Equipment”. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 34 Adapter for Instrument Channel Port. Soak them in the detergent solution, then reprocess them as described in Section 3.9, “Cleaning, Disinfection and Sterilization Procedures for Removable Parts and Cleaning Equipment”. Channel Cleaning Adapter Immerse tip of Channel Cleaning Adapter and activate suction. Figure 3.14 OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 35 Injection Tube (MH-946) cannot be used. Using such models may result in instrument damage. Attach the All-channel Irrigator’s Channel cap to the Instrument Channel Port (see Figure 3.16). Attach the All-channel Irrigator’s Lock cover to the Air/Water and Suction Cylinders (see Figure 3.16). OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 36 However, do not use excessive force when connecting it, as the Luer lock on the Main Body may be damaged. In addition, do not hold the Intake Tube’s port when operating the syringe, as this part may be damaged. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 37 Soak the endoscope and All-channel Irrigator (CW-3), for the amount of time and at the temperature recommended by the detergent manufacturer. Removing and Rinsing the Endoscope and all Equipment Remove the Endoscope and all equipment from the detergent solution and place in clean water. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 38 Fill a basin with detergent solution at a temperature and concentration recommended by the manufacturer. Use a basin which is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to completely immerse the endoscope. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 39: High Level Disinfection

    After manual cleaning, disinfect the endoscope according to the procedure described below. Equipment Needed Prepare the following equipment: • Personal Protective Equipment • Lint-free Cloth • Large Basin • Disinfectant Solution • All-channel Irrigator (CW-3) OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 40 Soaking the Endoscope and Cleaning Equipment Soak the endoscope and cleaning equipment for the amount of time and at the temperature recommended by the disinfectant manufacturer. It is recommended to use a timer to monitor soaking time. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 41: Rinsing After High Level Disinfection

    Endoscope, All-channel Irrigator. Connect the All-channel Irrigator to the Endoscope. Using the 30 cm (30 ml) syringe, flush 150 cm (150 ml) of air through the Air/Water and Suction Channel. Disconnect the All-channel Irrigator. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 42 Use a sterile lint-free cloth to thoroughly wipe dry the external surfaces of the Endoscope and All-channel Irrigator. Use a sterile lint-free cloth moistened with 70% ethyl or isopropyl alcohol to thoroughly wipe the external surfaces of the Endoscope and All-channel Irrigator. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 43: Sterilization

    Parameters described in Section 2.5, “ETO Gas Sterilization” and the sterilizer manufacturer’s instructions. Aerate the components following the Minimum Aeration Parameters specified in Section 2.5, “ETO Gas Sterilization”. Store the components following the instructions given in Chapter 5, “Storage and Disposal”. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 44: Cleaning, Disinfection And Sterilization Procedures For Removable Parts And Cleaning Equipment

    Clean the bristles and crevices of the brush while it is immersed in detergent solution. Using the 30 cm (30 ml) syringe, flush the interior and recessed parts of the Biopsy Valve and while it is immersed in detergent solution. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 45 Attach the 30 cm (30 ml) syringe to the Channel Cleaning Adapter and flush the tube with disinfectant solution. Ensure that all air bubbles are expelled. Using a clean, lint-free cloth, wipe away any air bubbles adhering to surfaces. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 46 Remove them from sterile water. Attach the 30 cm (30 ml) syringe to the Channel Cleaning Adapter and flush air to remove water from the inside of the tube. Wipe and dry their outer surfaces with a sterile lint-free cloth. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 47 Parameters described in Section 2.5, “ETO Gas Sterilization” and the sterilizer manufacturer’s instructions. Aerate the components following the minimum aeration parameters specified in Section 2.5, “ETO Gas Sterilization”. Store the components following the instructions given in Chapter 5, “Storage and Disposal”. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 48 Steam sterilize the instrument according to the parameters described in Section 2.6, “Steam Sterilization (Autoclaving) of Accessories” and the sterilizer manufacturer’s instructions. Following steam sterilization (autoclaving), let all components gradually cool down to room temperature. Sudden changes in temperature may damage the instruments. OSF-3 ENDOSCOPE REPROCESSING MANUAL...

  • Page 49: Chapter 4 Washing And Disinfection Equipment

    Chapter 4 Washing and Disinfection Equipment Washing and Disinfection Equipment The endoscope is compatible with some endoscope reprocessors recommended by Olympus. Refer to the instruction manual of endoscope reprocessor for details on operation. • Thoroughly clean the endoscope as described in Chapter 3, “Cleaning, Disinfection and Sterilization Procedures”...
  • Page 50 • Olympus confirms validation of the endoscope reprocessors recommended by Olympus only. If using endoscope reprocessor that are not recommended by Olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of reprocessing endoscope including all channels.

  • Page 51: Chapter 5 Storage And Disposal

    Make sure that the Insertion Tube hangs vertically and as straight as possible. Disposal When disposing of the endoscope, or any of its components (such as valves), follow all applicable national and local laws and guidelines. OSF-3 ENDOSCOPE REPROCESSING MANUAL...
  • Page 55 ©1997 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION. Trademarks, product names, logos, or trade names used in this document are generally registered trademarks or trademarks of each company.
  • Page 56 Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111 Distributed by 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610, U.S.A. Fax: (484)896-7128 Telephone: (484)896-5000 One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A. Fax: (845)398-9444 Telephone: (845)398-9400 5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A.

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