System Guide Endoscopy Instructions for Use

Contents 1 Introduction... 5 1.1 Potential Hazards and Signal Words... 6 1.2 Symbols... 7 2 Use of Endoscopic Equipment... 8 2.1 Inspection Before Each Use... 9 3 Energetic Applications... 13 3.1 Safety Precaution for Electro-Medical Equipment... 13 3.2 Light... 15 3.3 HF Surgery... 19 3.4 Laser Surgery... 29 4 Indications and Contraindications... 32 4.1 Arthroscopy... 32 4.2 ENT (Ear, Nose, Throat)... 32 4.3 Hysteroscopy... 33 4.4 Laparoscopy/Thoracoscopy... 35 4.5 Urology... 38 5 Reprocessing... 40 5.1 General Policy... 40 5.2 Reprocessing Procedures and Agents... 41 5.3 Health and Safety at Work... 43 5.4 Decontaminating the Surface of Electrical Units... 43 5.5 Preparation for Reprocessing at the Point of Use... 44 5.6 Manual Cleaning... 47 5.7 Ultrasonic Cleaning... 55 5.8 Manual Disinfection... 56 5.9 Automatic Cleaning/Disinfection... 61 5.10 Maintenance... 65 5.11 Steam Sterilization... 67 5.12 Gas Sterilization... 71 5.13 Other Sterilization Processes... 73 5.14 Storage and Handling... 74 6 Service... 78 6.1 Repairs... 78

7 Appendix... 81

1 Introduction Olympus instructions for use have been prepared to provide the user with all the necessary knowledge about the safe use of Olympus endoscopes and their related accessories. For further questions about how to use the products, about the products’ safety, or about this or other Olympus documents, feel free to contact your local Olympus representative or visit our website at www.olympus-oste.eu Product-specific instructions for use Olympus products are supplied with product-specific instructions for use, which give all details necessary for the use of the product. Some product-specific instructions for use make reference to the “System Guide Endoscopy”. In these cases, all the related information given in the “System Guide Endoscopy” is applicable to the product. If the information given in the “System Guide Endoscopy” is not applicable to a certain product, specific information is given in the product-specific instructions for use. System Guide Endoscopy The system-related instructions for use “System Guide Endoscopy” combine information on those topics that apply to many instruments. Therefore, the “System Guide Endoscopy” must be considered as part of the instructions for use. The “System Guide Endoscopy” applies to all products manufactured or distributed by Olympus Winter & Ibe, Germany, that reference to the “System Guide Endoscopy”. •• To make sure that you use the most recent version of the “System Guide Endoscopy”, check our website (www.olympusoste.eu). Carefully read all instructions for use •• Before use, carefully read the product-specific instructions for use, the “System Guide Endoscopy” (this document), and all instructions for use pertaining to additional equipment used in the procedure. 5

•• Follow all instructions given in these documents. Failure to understand these instructions may result in: -- Death or severe injury to the patient -- Severe injury to the user -- Severe injury to a third party -- Damage to the equipment Use of instructions for use Instructions for use contain valuable specifications, care, and problem-solving information which will help ensure safe and effective operation of the equipment. •• Keep instructions for use in a safe, accessible location.

1.1 Potential Hazards and Signal Words Olympus instructions for use include safety information which help the user to identify potential hazards and to avoid them. Olympus instructions for use highlight potential hazards by using three signal words: -- Danger -- Warning -- Caution In addition, the signal word Note has been introduced for helpful information. DANGER Indicates an imminently hazardous situation which, if not avoided, may result in death or serious injury. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. This signal word may also be used to highlight unsafe practices or potential equipment damage.

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NOTE Indicates additional helpful information.

1.2 Symbols Potential hazards, mandatory actions, prohibitions, and user actions are illustrated using the same symbol shapes throughout the “System Guide Endoscopy”. Hazard alert An equilateral triangle is used to convey hazard alert messages, regardless of their hazard level. Hazard level is conveyed by use of the appropriate signal word as described above. Mandatory actions A solid color circle is used to signify a mandatory action. Prohibition A circular band with a 45° diagonal slash from upper left to lower right is used to indicate prohibition. User actions •• A bullet at the beginning of a sentence indicates a required user action.

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2 Use of Endoscopic Equipment User qualification The user of endoscopic equipment must be a physician or medical personnel under the supervision of a physician. The user must have received sufficient training in clinical procedures. Olympus instructions for use do not explain or discuss clinical procedures. Spare equipment •• Always have spare equipment available in order to replace the equipment in case of a malfunction. WARNING Infection control risk with reusable equipment Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel. •• Properly reprocess all reusable equipment before first and each subsequent use following the instructions in this “System Guide Endoscopy” and in the product-specific instructions for use. WARNING Infection control risk with sterile, single-use equipment The equipment is delivered in a sterilized condition. •• Use only if the package is undamaged. •• Only open the package immediately before use. •• Do not use the equipment after its expiration date (if an expiration date is given). •• Dispose of expired equipment according to national and local laws and guidelines. Instrument compatibility The combinations of equipment and accessories that can be used with a certain product are listed in their product-specific instructions for use. The section is headed “Compatible Components” or “Compatible Equipment”. New products released after the introduction of a product may also be compatible for use. For details, contact Olympus.

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WARNING Risk of injury or equipment damage Using incompatible equipment can result in patient injury and/or equipment damage. If combinations of equipment other than those listed in the “Compatible Components” section are used, the full responsibility is accepted by the user.

2.1 Inspection Before Each Use Before each use, perform the following inspection in addition to that described in the product’s product-specific instructions for use. General inspection •• The product must be free of damage (e.g., dents, cracks, bends). •• The product must be free of dirt. •• The product must be free of remaining cleaning agents or disinfectants. •• Make sure that no parts are missing or loose (e.g., sealing rings, sealing caps). •• Make sure that connecting elements between instruments function properly. •• Inspect working channels for free passage. •• Make sure that all instrument parts/modules of an instrument system are assembled correctly and properly fixed (e.g., electrodes, knives, etc.). Inspecting telescopes

•• Inspect for debris on the objective window, the ocular window and the light-guide connector. 9

•• The telescope’s image must not be cloudy, out of focus or dark. •• Make sure that there is efficient light transmission from the light-guide connector to the distal end. If in doubt, compare the telescope’s light transmission with that of a new telescope. Inspecting light-guide cables •• Make sure that efficient light transmission is obtained. If in doubt, compare the light-guide cable’s light transmission with that of a new light-guide cable.

•• Inspect for cuts or other damages to the cable’s outer sleeve. •• Visually inspect the connector to be plugged into the light source. Make sure that the cover glass is not damaged. Inspecting HF cables

•• Make sure that the cable is not broken. •• Make sure that the insulation is not defective. •• Make sure that connectors are not damaged (e.g., dents, cracks, bents) and free of corrosion.

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Inspecting electrodes

•• Make sure that contact surfaces are free of damage, corrosion, and/or wear. •• Make sure that the insulation is not damaged.

•• Make sure that the HF-resection electrodes are securely attached. To do so, hold the working element in one hand. With the other hand, hold the electrode guiding tube. Pull slightly at the electrode. •• Make sure that the electrode moves smoothly and freely within the assembled instrument.

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Inspecting hand instruments

•• Make sure that the jaws and the handle move freely and are properly attached to the instrument. •• Make sure that the electrode’s proximal part is not bent. •• Make sure that the shaft’s insulation is not damaged. •• Make sure that the jaws insert can be inserted smoothly in the handle. •• Test scissors for cutting ability. •• Make sure that the sealing cap is not damaged (e.g., cracks).

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3 Energetic Applications 3.1 Safety Precaution for Electro-Medical Equipment 3.1.1 General The following instructions, based on the Notification No. 495 issued by the Pharmaceutical and Supply Bureau of the Ministry of Health and Welfare, Japan, June 1, 1972, describe general precautions which should be taken in the use of electro-medical equipment to ensure the safety of the patient, operator and surroundings. In regard with specific safety precautions for particular types of equipment, refer to the individual operation manuals. 3.1.2 Installation 1. The equipment should not be installed in a location on which liquids may splash. 2. Avoid environmental conditions that are likely to be adversely affected by atmospheric pressure, temperatures, humidity, ventilation, sunlight, dusty, salty or sulfureous air, etc. 3. Exercise care so that the equipment is neither inclined nor subjected to vibration and impacts. (Including during transportation.) 4. Never install and operate the equipment where there is a risk of flammable gases. 5. The AC mains to which the equipment is connected should supply a power appropriate for the input frequency, rated voltage and amperage of the equipment. 6. Check the conditions of batteries (discharge, polarity, etc.) 7. Earth the equipment effectively.

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3.1.3 Before use 1. Check electrical contacts of switches, polarity, dial setting, indicators, etc. and make sure that the equipment functions properly. 2. Make sure that the equipment is earthed effectively. 3. Make sure that all cords are connected correctly and securely. 4. Consideration should be taken if the equipment is used in conjunction with other instruments so that inaccurate diagnosis or a hazard will not result. 5. Check the external circuit directly connecting to the patient. 6. Check the batteries. 3.1.4 During use 1. A prolonged use or a dosage more than necessary for diagnosis and treatment may compromise patient safety. 2. Keep an eye continuously on the equipment at large as well as the patient for abnormality. 3. If any abnormality with the equipment or the patient is detected, take appropriate measures, e.g. by stopping the equipment in such a matter that it does not impair the patient safety. 4. Pay attention so that the patient does not come into contact with the equipment. 3.1.5 After use 1. After setting control switches, dials, etc. back to the home position in accordance with the procedures as prescribed, turn off the power switch. 2. When unplugging the connector, do not yank at the cord. Grasp the plug and pull to disconnect. 3. Storage -- The equipment should not be stored in a location on which liquids may splash.

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-- Avoid environmental conditions that are likely to be adversely affected by atmospheric pressure, temperatures, humidity, ventilation, sunlight, dusty, salty or sulfereous air, etc. -- Exercise care so that the equipment is neither inclined nor subjected to vibration and impacts. -- Do not store the equipment where there is a risk of flammable gases. 4. After accessories, cords, leads, etc. have been cleaned, arrange them neatly, then put in storage. 5. During storage keep the equipment clean and ready for next use. 3.1.6 Service and maintenance 1. If any failure has developed, leave repairs to the specialist. Attach appropriate information to the defective equipment and call qualified service personnel. 2. The user should not modify the equipment. 3. Maintenance and inspection -- Inspect the equipment and accessories periodically. -- When using the equipment after an extended period of time, make sure it functions normally and safely. For specific safety precautions of particular equipment, refer to the product-specific instructions for use.

3.2 Light Energy emission of light sources Light sources emit large amounts of light energy and thermal energy. As a result: -- The light-guide connector and the telescope’s distal end become extremely hot. -- The light energy is concentrated in a relatively small area.

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Risks related to light sources -- Thermal injury to the patient’s tissue (e.g., from prolonged exposure to the intense illumination in cavities with small lumens, or if the telescope’s distal end is placed into close proximity with the tissue). -- Burns to the patient’s or user’s skin. -- Burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials, etc.). Safety precautions •• Avoid prolonged exposure to intense illumination. •• Use the minimum level of illumination necessary to satisfactorily illuminate the target area. •• Do not place the telescope’s distal end or the light-guide connector on the patient’s skin, on flammable materials, or on heat-sensitive materials. •• Do not touch the telescope’s distal end or the light-guide connector.

•• Turn the light source off when detaching the telescope from the light-guide cable. •• Allow the telescope and the light-guide cable to cool down after use.

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Adapters on the telescope’s light-guide connector Light-guide adapters allow the telescope to be connected to lightguide cables of various manufacturers.

1) Olympus OES light-guide cable and Storz light-guide cables 2) Wolf light-guide cables 3) Olympus OES Pro and ACMI light-guide cables Adapters on the light-guide cable’s connector plug

Light-guide adapters allow the light-guide cable to be connected to light sources of various manufacturers. The nested adapter A3200 allows the connection to an Olympus light source. •• To use other adapters, remove adapter A3200 and attach the required adapter. CAUTION Risk of loss in light transmission •• When using screw-type adapters, make sure to screw the adapter tightly onto the corresponding connector.

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NOTE Light-guide cable adapters Olympus recommends the use of an Olympus light-guide cable and an Olympus light source. Only this combination will guarantee optimum illumination of the endoscopic image and excellent color reproduction. Interferences of light sources with imaging equipment Video systems feature different brightness control functions, such as an electronic shutter and an auto focus function. These mechanisms control the brightness of the video image on the monitor screen but do NOT control the light source’s output. In the case of improper settings of the camera and light source, the light source might be set to full power output, although this is not visible on the monitor screen. Such improper settings lead to enhanced heat emission at the telescope. •• For further information on the proper connection of light sources and video systems, refer to the product-specific instructions for use. Testing the light source’s brightness control function

•• Move the endoscope’s distal end towards an object. The light emission from the telescope’s distal end must decrease.

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•• Move the endoscope’s distal end away from an object. The light emission from the telescope’s distal end must increase.

3.3 HF Surgery An electrical current applied to biological tissue generates three effects: -- a thermical effect, generating heat -- a Faraday effect, stimulating nerves and muscles -- an electrolytical effect, causing movement of ions Effects of HF current In HF surgery, the Faraday effect is avoided by using highfrequency alternating current with a frequency of more than 300 kHz. This current only generates heat. This heat can be used for three types of application: -- thermal coagulation of tissue -- cutting of tissue -- vaporisation In thermal coagulation, the electrical current heats the tissue only slowly. The water inside the tissue evaporates slowly and cellular proteins are denaturated, thus resulting in coagulation of the tissue.

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For cutting tissue, the electrical current heats the tissue very quickly. The temperature of the tissue inside the cells increases quickly and the intracellular water evaporates, destroying cell membranes. For vaporisation, the electrical current is set to high values. The intracellular water evaporates immediately, resulting in shrinked tissue and a large coagulation zone for TURis or TCRis. Bipolar HF surgery

In bipolar HF surgery, the electrosurgical current passes between the two electrodes of the instruments (e.g., the jaws of a bipolar forceps). On the small surface between both electrodes, a high current density accumulates, which creates enough heat to coagulate and/or cut tissue. As a result, bipolar HF surgery only requires electrosurgical current to be conducted over a very short distance through the patient’s body.

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Monopolar HF surgery I HF A

P

I HF In monopolar HF surgery, the electrosurgical current passes from the point-shaped “active” electrode (A in the diagram) to the larger “patient plate” (P). On the small surface of the active electrode, a high current density accumulates, which creates enough heat to coagulate, cut and/or vaporize tissue. Active electrodes as described in this “System Guide Endoscopy” are: -- all HF electrodes -- HF-resection electrodes (in resectoscopes) -- monopolar hand instruments (e.g., monopolar forceps and scissors) Other terms used for a patient plate are: -- neutral electrode -- indifferent electrode -- p-plate

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