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Olympus VISERA ENF-V2 Instructions Manual

Visera rhino-laryngo videoscope
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INSTRUCTIONS
VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF TYPE V2
(For PAL type only)

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Summary of Contents for Olympus VISERA ENF-V2

  • Page 1 INSTRUCTIONS VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2 (For PAL type only)

  • Page 3: Table Of Contents

    Contents Contents Symbols..................Important Information — Please Read Before Use....Intended use .................... Applicability of endoscopy and endoscopic treatment ......Instruction manual ..................User qualifications ..................Instrument compatibility ................Reprocessing before the first use/reprocessing and storage after use ..Spare equipment..................Maintenance management ...............
  • Page 4 Contents Chapter 6 Recommended Reprocessing Methods and Chemical Agents ............. Compatibility summary..............Detergent solution ................Ultrasonic cleaning................Disinfectant solution ................ Rinsing water .................. Automatic cleaning/disinfection............Ethylene oxide gas sterilization............Steam sterilization (autoclaving) of accessories ......Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments ........

  • Page 5: Symbols

    Symbols Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows: Refer to instructions. Caution Type BF applied part Endoscope Manufacturer Authorized representative in the European Community Lot number Serial number VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 6: Important Information - Please Read Before Use

    Important Information — Please Read Before Use Intended use This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, and other ancillary equipment for endoscopic diagnosis within the ear, nasal lumens and airway anatomy (including nasopharyngeal and bronchus).

  • Page 7: User Qualifications

    Important Information — Please Read Before Use User qualifications If there is an official standard of the qualification of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as the academic society of endoscopy, follow the standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of otorhinolaryngology, etc.).

  • Page 8: Spare Equipment

    Equipment which has been disassembled, repaired, altered, changed or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner. Signal words...

  • Page 9: Warnings And Cautions

    Important Information — Please Read Before Use Warnings and cautions Follow the warnings and cautions given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter. • Push the video connector until it clicks into the video system center, then confirm that the video connector is securely attached by pulling it gently.
  • Page 10 Important Information — Please Read Before Use • Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be sure to be prepared to deal with any bleeding. When withdrawing the endoscope, observe the inside of the nasal cavity to ensure that there is no bleeding. Even when the endoscope has been withdrawn without bleeding, do not allow the patient to blow his or her nose strongly because this could cause it to start bleeding.
  • Page 11 Important Information — Please Read Before Use  Pay special attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system. When using a light source and video system that are compatible with the light source’s automatic brightness control function, make sure to use this function.
  • Page 12 In case fogging is found to be apparent, please stop using the scope immediately. 1 Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. •...
  • Page 13 Important Information — Please Read Before Use • Do not insert the video connector while the electrical contacts are wet and/or dirty. The endoscopic image may not be visible. • Turn the video system center OFF before connecting or disconnecting the video connector to/from the video system center.

  • Page 14: Precaution For Disappeared Or Frozen Endoscopic Image

    Important Information — Please Read Before Use Precaution for disappeared or frozen endoscopic image • If the endoscopic image unexpectedly disappears or the frozen image cannot be restored during an examination, immediately stop using the instrument and withdraw the endoscope from the patient. Continued use of the endoscope in such condition may cause patient injury, such as bleeding and/or perforation.

  • Page 15: Examples Of Inappropriate Handling

    Important Information — Please Read Before Use Examples of inappropriate handling Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility.
  • Page 16 Important Information — Please Read Before Use VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 17: Chapter 1 Checking The Package Contents

    Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not cleaned, disinfected or sterilized before shipment.

  • Page 18: Chapter 2 Instrument Nomenclature And Specifications

    Chapter 2 Instrument Nomenclature and Specifications Chapter 2 Instrument Nomenclature and Specifications Nomenclature 8. ETO cap 4. Light guide connector 7. Venting connector Universal cord Video cable Serial number Light guide 6. UP mark Electrical contacts 5. Video connector VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...
  • Page 19 Chapter 2 Instrument Nomenclature and Specifications ® 9. Identification mark for STERRAD 200/NX material compatibility 2. UP/DOWN angulation control lever Control section Boot 3. Remote switches Insertion tube/working length Distal end 3. Remote switches 1. Bending section VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 20: Endoscope Functions

    Chapter 2 Instrument Nomenclature and Specifications Endoscope functions 1. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 2. UP/DOWN angulation control lever When turned in the “U” direction, the bending section moves UP; when moved in the “D”...

  • Page 21: Specifications

    Chapter 2 Instrument Nomenclature and Specifications Specifications Environment Operating Ambient temperature 10 – 40C (50 – 104F) environment Relative humidity 30 – 85% Atmospheric pressure 700 – 1060 hPa (0.7 – 1.1 kgf/cm (10.2 – 15.4 psia) Standard storage Ambient temperature 5 –...
  • Page 22 Chapter 2 Instrument Nomenclature and Specifications Medical Devices This device complies with the Directive requirements of Directive 93/42/EEC concerning medical devices. (for PAL type only) Classification: Class II a Applied standards; This instrument complies with the IEC 60601-1-2: 2001 standards listed in the left column. IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 CISPR 11 of emission:...

  • Page 23: Chapter 3 Preparation And Inspection

    If any irregularities are suspected after inspection, follow the instructions as described in Chapter 10, “Troubleshooting”. If this instrument malfunctions, do not use it. Return it to Olympus for repair as described in Section 10.3, “Returning the endoscope for repair” on page 75.

  • Page 24: Preparation Of The Equipment

    Chapter 3 Preparation and Inspection Preparation of the equipment Prepare the equipment shown in Figure 3.1, (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use.

  • Page 25: Preparation And Inspection Of The Endoscope

    Chapter 3 Preparation and Inspection Preparation and inspection of the endoscope Clean and disinfect or sterilize the endoscope as described in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”. Inspection of the endoscope Inspect the control section, video connector and light guide connector section for excessive scratching, deformation or other irregularities.
  • Page 26 Chapter 3 Preparation and Inspection Using both hands, bend the insertion tube into a semicircle. Moving your hands as shown by the arrows, confirm that the entire insertion tube can be smoothly bent to form a semicircle (see Figure 3.3). Figure 3.3 Inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.

  • Page 27: Preparation, Inspection And Connection Of Ancillary Equipment

    Chapter 3 Preparation and Inspection  Inspection for smooth operation Turn the UP/DOWN angulation control lever slowly in each direction until it stops. Confirm that the bending section angulates smoothly and correctly and that maximum angulation can be achieved. Turn the UP/DOWN angulation control lever slowly to its straight (neutral) position.

  • Page 28: Inspection Of The Endoscopic System

    In case fogging is found to be apparent, please stop using the scope immediately. 1 Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. Before inspection, wipe the objective lens with a clean, lint-free cloth moistened with 70% ethyl alcohol.
  • Page 29 Chapter 3 Preparation and Inspection Turn ON the video system center, light source, video monitor and inspect the endoscopic image as described in their respective instruction manuals. Adjust the brightness level as appropriate. While observing the palm of your hand, confirm that the examination light is output and that the endoscopic image is free from noise, blur, fog or other irregularities.

  • Page 30: Chapter 4 Operation

    If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it; leave it inside the patient and immediately contact Olympus. Forcibly withdrawing the endoscope may cause patient injury. • The temperature at the distal end of the endoscope may reach 50C due to intense endoscopic illumination, and may...
  • Page 31 Chapter 4 Operation • Turn the video system center ON to operate the light source’s automatic brightness function. When the video system center is OFF, it cannot operate the light source’s automatic brightness function, and the light intensity is set to the maximum level.

  • Page 32: Insertion

    Chapter 4 Operation There is a possibility that unrecognized damage may be caused when a high impact strikes the distal end. Be sure to contact Olympus for repair. Insertion Holding and manipulating the endoscope The control section of the endoscope is designed to be held in the left hand. The UP/DOWN angulation control lever can be operated using the left thumb.
  • Page 33 Chapter 4 Operation Insertion of the endoscope If necessary, apply a medical grade, water-soluble lubricant to the insertion tube. • The shape and size of the nasal cavity and its suitability for transnasal insertion may vary from patient to patient. No endoscope, including this one, can always be inserted transnasally with all patients.

  • Page 34: Withdrawal Of The Endoscope

    Olympus. Forcibly withdrawing the endoscope may cause patient injury. Operate the UP/DOWN angulation control lever as necessary to guide the distal end for the insertion and observation.

  • Page 35: Chapter 5 Reprocessing: General Policy

    Chapter 5 Reprocessing: General Policy Chapter 5 Reprocessing: General Policy Notes for cleaning, disinfection and sterilization The medical literature reports incidents of cross contamination resulting from improper cleaning, disinfection or sterilization. It is strongly recommended that all individuals engaged in reprocessing have a thorough understanding of the following and observe the instructions given in this manual.
  • Page 36 When using these disinfection agents and endoscope reprocessor, follow their instruction manual. Olympus does not assure the effect of cleaning, disinfection and sterilization in endoscope reprocessors. Contact the manufacturers of those disinfection agents and endoscope reprocessor.
  • Page 37 Chapter 5 Reprocessing: General Policy • Patient debris and reprocessing chemicals are hazardous. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During cleaning and disinfection or sterilization, wear appropriate personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.
  • Page 38 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 39: Chapter 6 Recommended Reprocessing Methods And Chemical Agents

    Chapter 6 Recommended Reprocessing Methods and Chemical Agents Compatibility summary The materials and construction of Olympus endoscopic instruments may not be compatible with certain reprocessing methods. Olympus distinguishes validated methods in terms of the following two points. • Microbiological efficacy •...
  • Page 40 – incompatible Table 6.1 1 The flexible endoscope is compatible with some washer/disinfectors such as the ETD system distributed by Olympus. Refer to the respective instruction manual for details on operation. For any other details, please contact your local Olympus organization.
  • Page 41 2 For any other details, and usage of other kind of disinfectants, please contact your local Olympus organization. 3 For any other details, please, contact your local Olympus organization. 4 An older generation of this endoscope model without an identification ®...

  • Page 42: Detergent Solution

    There is an infection risk when using insufficient cleaning agents. Use only solutions whose compatibility for cleaning endoscopic instruments is certified by manufacturers, and which are approved by a competent authority. Incompatible detergents may considerably damage Olympus endoscopes and accessories. VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 43: Ultrasonic Cleaning

    Use only solutions whose compatibility for cleaning endoscopic instruments is certified by manufacturers, and which are approved by a competent authority. Incompatible detergents may considerably damage Olympus endoscopic instruments. • For details on the operation of the ultrasonic cleaner, refer to its instruction manual.

  • Page 44: Disinfectant Solution

    In general, 2.0% to 3.5% glutaraldehyde solutions, when used according to the manufacturer’s instructions for achieving disinfection, are compatible with Olympus endoscopes. Contact Olympus for the names of specific brands that have been tested for compatibility with this endoscope. For information on the germicidal effectiveness of any solution, refer to the solution’s instructions or contact the manufacturer of the disinfectant.

  • Page 45: Automatic Cleaning/Disinfection

    The flexible endoscope is compatible with some washer/disinfectors such as the ETD system distributed by Olympus. Refer to the respective instruction manual for details on operation. For any other details, please contact your local Olympus organization.  Automatic cleaning/disinfection procedure •...

  • Page 46: Ethylene Oxide Gas Sterilization

    Chapter 6 Recommended Reprocessing Methods and Chemical Agents Ethylene oxide gas sterilization This instrument and other accessories listed in Table 6.1 on page 36 are compatible with ethylene oxide gas sterilization and can be sterilized by ethylene oxide gas and aerated within the parameters given in Table 6.2. When performing sterilization, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.
  • Page 47 Chapter 6 Recommended Reprocessing Methods and Chemical Agents ETO cap (MB-156) Connecting the ETO cap Figure 6.1 Ethylene oxide gas exposure parameters (gas mixture 20% EtO/80% CO Process Parameters Ethylene oxide gas Temperature  sterilization Pressure 0.1 – 0.17 MPa Humidity Exposure time 1.75 hours...

  • Page 48: Steam Sterilization (Autoclaving) Of Accessories

    Chapter 6 Recommended Reprocessing Methods and Chemical Agents Steam sterilization (autoclaving) of accessories The accessories listed in Table 6.1 on page 36 are compatible with steam sterilization (autoclaving) and can be sterilized by steam within the parameters given in Table 6.3 on page 45. When steam sterilizing, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.
  • Page 49 Olympus instruments. Olympus recommends that the instruments are autoclaved for 5 minutes at 132C – 134C in a prevacuum sterilizer. Olympus products are designed for steam sterilization according to the following standards: ...
  • Page 50 Chapter 6 Recommended Reprocessing Methods and Chemical Agents Recommend water and steam quality acc. to EN 285: 1996 Condensate Feed-water Coke residues 1.0 mg/kg 10 mg/l 0.1 mg/kg 1 mg/l 0.1 mg/kg 0.2 mg/l 0.005 mg/kg 0.005 mg/l 0.05 mg/kg 0.05 mg/l Traces of heavy metals (except Fe, Cd, Pb) 0.1 mg/kg...

  • Page 51: Chapter 7 Cleaning, Disinfection And Sterilization Procedures For Endoscopic Instruments

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments • Do not coil the endoscope’s insertion tube, universal cord or the video cable with a diameter of less than 10 cm. The endoscope can be damaged if coiled too tightly.
  • Page 52 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Sterilization tray (WA05991A) ETO cap (MB-156) Leakage tester (WA23070A) Leakage tester (MB-155) Maintenance unit (MU-1) • Personal protective equipment • De-ionized water (Aq. Dest.) • Soft-bristled brush • Detergent solution •...
  • Page 53 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Reprocessing equipment parts and functions For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used.  ETO cap (MB-156) ® When performing gas sterilization (ethylene oxide gas, STERRAD 50/100S etc.), the ETO cap must be attached to the venting connector to equalise the outer and inner pressure (see Figure 7.2).
  • Page 54 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Inspection of the equipment For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used. All equipment mentioned below are items that are subject to wear.

  • Page 55: Cleaning, Disinfection And Sterilization Procedures

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Cleaning, disinfection and sterilization procedures After the procedure, clean, disinfect or sterilize the endoscope according to the procedures described below. Endoscope reprocessing summary chart Withdrawal of the endoscope Precleaning (Section 7.3 on page 52) Transportation of the endoscope (Section 7.4 on page 54) Leakage testing...

  • Page 56: Precleaning

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments • Do not store disinfected instruments. Use them immediately after disinfection or forward them to the following sterilization process. If stored instruments are used, refer to your local regulations and/or guidelines. •...
  • Page 57 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Preparation Turn the video system center and light source OFF. Prepare detergent solution at the temperature and concentration recommended by the detergent manufacturer in a 500 cm (500 ml) container. Prepare de-ionized water (Aq.

  • Page 58: Transportation Of The Endoscope

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Transport the endoscope and the container containing the other equipment to the reprocessing area. Transportation of the endoscope Transporting within the hospital • After Section 7.3, “Precleaning” on page 52, keep the endoscope in a container (WA05991A) with a lid to avoid possible environmental or personnel contamination during transportation.

  • Page 59: Leakage Testing

    This means that water will be able to penetrate the inside of the endoscope. If you locate a leak, remove the endoscope from the water and contact Olympus. VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...
  • Page 60 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments • Always disconnect the leakage tester connector from the light source or maintenance unit before detaching the leakage tester’s connector cap from the venting connector. Detaching the leakage tester’s connector cap from the venting connector while the leakage tester is still connected to the light source will not allow the endoscope to depressurize properly and may damage the endoscope.
  • Page 61 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments (green) (red) Pressure release lever (Decompression) Figure 7.7 • When decompressing, allow air to escape from the endoscope until 0 kPa is indicated on the display. • The leakage test pressure must not exceeded 27 kPa/the green scale area.
  • Page 62 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Press the hand pump until a pressure between 19 and 27 kPa is indicated on the pressure display. The pointer must be within the green area on the pressure display. To detect slight leakage of water, pressurize up to nearly 27 kPa.
  • Page 63 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments  Leakage testing with leakage tester (MB-155) Fill a basin with clean water. Use a basin which is at least 25 (W) × 10 (H) × 50 (D) cm in size and deep enough to allow the endoscope to be completely immersed.

  • Page 64: Manual Cleaning

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Manual cleaning Endoscopic instrumentation must be meticulously cleaned prior to disinfection or sterilization. Thorough cleaning removes both micro-organisms and organic material. Failure to remove organic material decreases effectiveness of the disinfection or sterilization procedure.
  • Page 65 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Preparation Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin which is at least 25 (W) × 10 (H) × 50 (D) cm in size and deep enough to allow the endoscope to be completely immersed.
  • Page 66 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Removing and rinsing the endoscope and all reprocessing equipment Cleaning solutions may contain various aggressive compounds (e.g. chlorine) which damage the instrument by corrosion. To remove all residuals, rinse the instrument thoroughly with de-ionized water (Aq.

  • Page 67: Disinfection

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Soak the endoscope for minimum 1 hour at the temperature recommended by the detergent manufacturer. For information about the concentration and immersion time, refer to the instructions given by the detergent manufacturer.
  • Page 68 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Preparation Fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer. Use a basin which is at least 25 (W) × 10 (H) × 50 (D) cm in size and deep enough to allow the endoscope to be completely immersed.

  • Page 69: Rinsing And Drying After Disinfection

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments Rinsing and drying after disinfection • Carefully dry the electrical contacts of the video connector after performing the procedure described in this section. Otherwise, equipment damage can result. • Disinfectant solutions may contain various aggressive compounds (e.g.

  • Page 70: Automatic Cleaning/Disinfection

    The flexible endoscope is compatible with some washer/disinfectors such as the ETD system distributed by Olympus. Refer to the respective instruction manual for details on operation. For any other details please contact your local Olympus organization. VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 71: 7.10 Sterilization

    Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments 7.10 Sterilization  Ethylene oxide gas sterilization The endoscope can be sterilized by ethylene oxide gas. Prior to sterilization, perform the suitable process which is recommended by the regulation/guideline in your region. •...
  • Page 72 Chapter 7 Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments  Steam sterilization (autoclaving) Regarding the condition of steam sterilization, refer to Section 6.8, “Steam sterilization (autoclaving) of accessories” on page 44. After cleaning as described in Section 7.6, “Manual cleaning” on page 60, steam sterilize (autoclave) according to the procedures given below.

  • Page 73: Chapter 8 Maintenance Procedures Of Equipments For Reprocessing

    Chapter 8 Maintenance Procedures of Equipments for Reprocessing Chapter 8 Maintenance Procedures of Equipments for Reprocessing • Clean and decontaminate the equipment after use. • If necessary, perform ultrasonic cleaning. • For compatible reprocessing methods, refer to Section 6.1, “Compatibility summary” on page 35. VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 74: Chapter 9 Storage, Transporting Outside The Hospital And Disposal

    Chapter 9 Storage, Transporting Outside the Hospital and Disposal Chapter 9 Storage, Transporting Outside the Hospital and Disposal Storage • The storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature. Do not store the endoscope in direct sunlight, at high temperature, in high humidity or exposed to X-rays and/or ultraviolet-rays.

  • Page 75: Transporting Outside The Hospital

    Chapter 9 Storage, Transporting Outside the Hospital and Disposal The storage life of sterilized instruments depends on the type of packaging and the storage conditions (refer to DIN 58 953, Teil 9, or local regulations). Double sterile package according to DIN 58 946, Teil 9 prolongs the storage life.

  • Page 76: Chapter 10 Troubleshooting

    Some problems that appear to be malfunctions may be correctable by referring to Section 10.1, “Troubleshooting guide”. If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to Olympus for repair. Olympus does not repair accessory parts. If an accessory part becomes damaged, contact Olympus to purchase a replacement.

  • Page 77: 10.1 Troubleshooting Guide

    Troubles or failures due to other causes than those listed below should be serviced. As repair performed by persons who are not qualified by Olympus could cause patient or operator injury and/or equipment damage, be sure to contact Olympus for repair according to Section 10.3, “Returning the endoscope for repair”...

  • Page 78: Withdrawal Of The Endoscope With An Abnormality

    If the endoscope or endo-therapy accessory cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it. If any irregularities are suspected, immediately contact Olympus. Forcibly withdrawing the endoscope or endo-therapy accessory may cause patient injury bleeding and/or perforation.

  • Page 79: 10.3 Returning The Endoscope For Repair

    Olympus. Olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-Olympus personnel. Before returning the endoscope for repair, contact Olympus. With the...

  • Page 80: Appendix

    New products released after the introduction of this instrument may also be compatible for use in combination with this instrument. For further details, contact Olympus. If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.
  • Page 81 Appendix Endoscopic equipment combinations Video monitor (OEV141, OEV142, OEV143, OEV201, OEV202, OEV203, OEV181H, OEV191) Endoscope ENF-V2 VISERA Pro video VISERA Pro light system center source 1 (OTV-S7Pro 1 (CLV-S40Pro VISERA video system VISERA xenon light center (OTV-S7V) source (CLV-S40) Video system (OTV-SI) EVIS EXERA II video EVIS EXERA II xenon light system center (CV-180)
  • Page 82 Cleaning and disinfection equipment Leakage tester Maintenance unit Ultrasonic cleaner (WA23070A) (MU-1) (KS-2) Leakage tester ETO cap (MB-156) (MB-155) Sterilization tray (WA05991A) 1 ETD series For any other details, please contact your local Olympus organization. 1 VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2...

  • Page 83: Emc Information

    Appendix EMC information  Guidance and manufacturer’s declaration — Electromagnetic emissions This model is intended for use by medical personnel in hospital environments and for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment.
  • Page 84 Appendix  Guidance and manufacturer’s declaration — Electromagnetic immunity This model is intended for use by medical personnel in hospital environments and for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment.
  • Page 85 Appendix IEC 60601-1-2 IEC 60601-1-2 IEC 60601-1-2 (2007, 2001) Compliance Immunity test (2014) (2007, 2001) Electromagnetic environment — level test level test level Guidance Voltage dips, 0% U < 5% U Same as left Mains power quality should be that of a short typical commercial or hospital (100% dip in U...
  • Page 86 Appendix IEC 60601-1-2 IEC 60601-1-2 IEC 60601-1-2 (2007, 2001) Compliance Immunity test (2014) (2007, 2001) Electromagnetic environment — level test level test level Guidance Radiated RF 3V/m (80 MHz – 3V/m (E Same as left Recommended separation distance IEC 61000-4-3 2.7 GHz) (80 MHz –...
  • Page 87 30 cm (12 inches) to any part of the video system center, including cables specified by Olympus. Otherwise, degradation of the performance of this equipment could result.  Guidance and manufacturer’s declaration — Cables used for EMC compliance testing Refer to the instruction manuals for each piece of equipment.
  • Page 89 ©2005 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 90 A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000 Olympus Tower 9F, 446, Bongeunsa-ro, Gangnam-gu, Seoul, Korea 135-509 Fax: (02)6255-3494 Telephone: (02)6255-3210 491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373...

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