ULTRA TELESCOPE Instructions for Use

Contents 1 General information... 5 1.1 User instructions... 5 1.2 Signal words... 5 1.3 Conventions throughout this document... 5 1.4 Trademarks... 6 1.5 Manufacturer... 6 2 Safety information... 7 2.1 Intended use... 7 2.2 Contraindications... 7 2.3 User qualification... 7 2.4 Environment of use... 8 2.5 General warnings and cautions... 8 3 Product description... 11 3.1 Scope of delivery... 11 3.2 Telescope... 11 3.3 Symbols... 13 3.4 Warranty... 14 4 Preparation... 15 4.1 Safety information for preparation... 15 4.2 Inspection... 15 4.3 Assembly and connection... 17 5 Use... 19 5.1 Safety information for use... 19 6 After use... 21 6.1 Removal and disassembly... 21 6.2 Preparation for reprocessing at the point of use... 21 7 Reprocessing... 23 7.1 Safety information for reprocessing... 23 7.2 General information for reprocessing... 24

7.3 Manual cleaning... 27 7.4 Manual disinfection... 29 7.5 Automated cleaning and thermal disinfection... 30 7.6 Maintenance... 33 7.7 General information for sterilization... 33 7.8 Validated sterilization methods... 34 7.9 Verified sterilization methods... 37 7.10 Storage and handling... 39 8 Repair, shipment and disposal... 40 8.1 Repair... 40 8.2 Shipment... 41 8.3 Disposal... 41 9 Compatible equipment... 42 10 Technical data... 44 10.1 General dimensions... 44 10.2 Specifications... 44 10.3 Ambient conditions... 44

General information

1 General information 1.1 User instructions •• Before use, thoroughly read the instructions for use. •• If the instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location.

1.2 Signal words The following signal words are used throughout this document. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. NOTICE Indicates a property damage message.

1.3 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2.

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General information •• Bullet points indicate individual actions or different options for action. -- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations.

1.4 Trademarks -- STERRAD® -- NXTM -- Cidex OPA® are trademarks of their respective owner.

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Safety information

2 Safety information 2.1 Intended use Telescope for diagnosis and visual observation of interventions in rhinoscopy, sinuscopy, skull base surgery, laryngoscopy, laryngostroboscopy, epipharyngoscopy, otoscopy and middle ear endoscopy. •• Do not use for any other purposes.

2.2 Contraindications There are no absolute contraindications. The operating physician must judge according to professional standards whether a specific procedure is appropriate or not.

2.3 User qualification Medical use This product is only intended to be used by a trained physician. These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of the product may only be performed by qualified hygiene personnel. Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product.

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Safety information

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Reprocessing This product must be reprocessed according to the applicable national and local standards and regulations.

2.5 General warnings and cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the dangers, warnings and cautions given in each chapter in this document or in the instructions for use of any product being used with this product. WARNING Risk of injury to the patient and/or the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury or damage to the product. •• Make sure to have the complete set of instructions for use. •• Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. WARNING Risk of injury to the patient and/or the user The use of a damaged product or of a product with improper functioning may cause an electric shock, mechanical injury, infection, and/or thermal injury. •• Before each use, observe the instructions in the section “Inspection” on page 15. •• Do not use a damaged product or a product with improper functioning.

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Safety information •• Replace a damaged product or a product with improper functioning. •• If a defect occurs during a procedure, immediately replace the product. WARNING Risk of injury to the patient There is a risk of an electric shock when using endoscopic equipment or when using endoscopic equipment in combination with energized endotherapy devices. The patient leakage currents may be additive. •• Only use F-Type applied part endoscopic equipment. •• Before each use, check the applied part classification of the endoscopic equipment and especially the energized endotherapy devices used during the procedure. •• Only use endoscopic equipment or endoscopic equipment in combination with energized endotherapy devices that meet at least the same requirements of applied part classification. This is particularly important if a type CF applied part endoscope is used. In this case a type CF applied part energized endotherapy device should be used to minimize total leakage current. •• For the applied part classification, refer to the respective instructions for use. WARNING Risk of injury to the patient There is a risk of electric shock when using light sources with noninsulated light-guide connectors. •• Only use light sources or light-guide cables that meet at least the same requirements of applied part classification. •• For the applied part classification, refer to the respective instructions for use. WARNING Risk of injury to the patient There is a risk of injury to the patient due to malfunction of the equipment. •• Always have spare equipment available. 9

Safety information WARNING Risk of injury to the patient and/or the user There is a risk of injury to the patient and/or the user caused by unauthorized repairs and product modification. Possible injuries include mechanical injuries, electric shock, burns, and toxication. •• Do not attempt to repair or modify the product. •• Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. •• Contact an Olympus representative or an authorized service center for repair information. CAUTION Risk of injury to the patient and/or the user Using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product. •• For information on compatible equipment, refer to the chapter “Compatible equipment” on page 42. NOTICE Risk of damage to the product The endoscope is a precise optical device. Careless handling may damage the endoscope. •• Always handle the endoscope with care. •• Do not hold the endoscope by the distal end only. •• Do not bend the insertion tube.

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Product description

3 Product description 3.1 Scope of delivery •• Before use, check that all items listed below are available. •• Contact an Olympus representative or an authorized service center if any items are missing or damaged. WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS470, WA4KS471: -- Telescope -- Instructions for use

3.2 Telescope A telescope is a rigid endoscope. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The endoscopic image can be viewed using the eyepiece cup or by connecting a compatible camera head. Telescopes are precise optical devices which are very sensitive to mechanical impacts. For information on compatibility, refer to the chapter “Compatible equipment” on page 42.

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Product description 3.2.1 Telescope Entire telescope

Main body

1) Insertion tube 2) Light-guide connector 3) Eyepiece cup 3.2.2 Distal end

1) Objective cover glass 2) Light emission surface 12

Product description 3.2.3 Eyepiece cup

1) Eyepiece cover glass 3.2.4 Direction of view

The direction of view is indicated in degree on the main body of the telescope.

3.3 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product.

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Product description Symbol

Explanation

Symbol

Explanation

Catalog number

Autoclavable

Serial number

CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/ EEC

Quantity of content

Federal (USA) law restricts this device to sale by or on the order of a physician

Manufacturer

Consult instructions for use

Date of manufacture

Storage conditions

Indicates a recovery/recyclable package or package material

Transport conditions

Green Dot-symbol for dual recycling system

Indicates the temperature limits to which the medical device can be safely exposed

Indicates the range of humidity to which the medical device can be safely exposed

3.4 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

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Preparation

4 Preparation 4.1 Safety information for preparation WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. •• Reprocess the product before first and each subsequent use. •• For reprocessing the product, observe the instructions in the chapter “Reprocessing” on page 23. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section “Inspection” on page 15. •• Do not use a damaged product. WARNING Risk of injury to the patient If the light-guide cable is not properly connected to the endoscope or the light source, the endoscopic image may suddenly disappear during the procedure. This may lead to mechanical injury to the patient. •• Properly connect the adapters to the light-guide cable and the endoscope. •• Properly connect the light-guide cable to the endoscope and the light source.

4.2 Inspection Inspection regarding reprocessing •• Make sure that the product has been properly reprocessed. •• Visually inspect the product thoroughly. The product must be visually clean.

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Preparation General inspection of the telescope

•• Check that the product has: -- no dents, cracks, bending, or deformations -- no deep scratches -- no corrosion -- no lens damages or cover glass damages -- no missing or loose parts •• Check all markings on the product for clear visibility. CAUTION Risk of injury to the user There is a risk of damaging the eye when looking into the distal end of the endoscope and the light source is switched on. •• Do not look into the distal end of the endoscope when the light source is switched on. Checking the light transmission •• Hold the distal end of the telescope against a lamp. •• Look into the light-guide connector of the telescope. Black dots indicate defective light-guide fibers. •• Do not use a telescope with more than 25 to 30% defective light-guide fibers.

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Preparation Checking the image quality •• Hold a piece of writing in the usual working distance from the objective cover glass. •• Check if the writing is clearly visible through the telescope. •• Check that the image is not cloudy, out of focus or dark. •• Only use the telescope if the writing is clearly visible through the telescope.

4.3 Assembly and connection If force is required for assembly: 1. Check the compatibility of the equipment. 2. If necessary, dispose of the product and use another one. 4.3.1 Selecting compatible system components •• Refer to the chapter “Compatible equipment” on page 42 to identify the compatible system components. •• Observe the instructions for use of the compatible system components. 4.3.2 Connecting the light-guide cable •• Refer to the chapter “Compatible equipment” on page 42 to identify the compatible light-guide cable. •• If applicable, remove inappropriate light-guide adapters from the telescope. •• Observe the instructions for use of the light-guide cable.

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Preparation

1. Connect the light-guide cable to the light-guide connector of the telescope. 2. Screw the light-guide cable onto the thread of the light-guide connector. 4.3.3 Connecting the video adapter and/or camera head •• Refer to the chapter “Compatible equipment” on page 42 to identify the compatible equipment. •• Observe the instructions for use of the compatible equipment.

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Use

5 Use 5.1 Safety information for use WARNING Risk of injury to the patient There is a risk of electric shock if the following conditions apply simultaneously: -- The telescope is inserted in the patient. -- The light-guide cable is connected to the telescope but not to the light source. -- The light source connector of the light-guide cable comes in contact with a conductive surface. •• Completely connect the endoscope before inserting the endoscope into the patient. WARNING Risk of injury to the patient When energized endoscopes are used in combination with HF surgical equipment, there are several risks of injury to the patient. •• Follow the instructions for use of all devices connected to the endoscope for safe application. CAUTION Risk of injury to the patient Light sources emit large amounts of energy. As a result the connectors of the endoscopic equipment and the distal end of the endoscope become hot. There is a risk of: -- thermal injury to the patient’s tissue (e.g., from prolonged exposure to the intense illumination in cavities with small lumens, or if the distal end of the endoscope is placed into close proximity to the tissue). -- burns to the patient’s or user’s skin. -- burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials). •• Do not place the endoscopic equipment on the patient’s skin, on flammable materials, or on heat-sensitive materials.

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Use •• Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area. Avoid prolonged exposure to intense illumination. •• Switch off the light source or set the light source to standby mode whenever the light source is not in use. CAUTION Risk of injury to the patient Light sources emit large amounts of energy. As a result, the temperatures in front of the light emission surface increase. There is a risk of thermal injury to the patient’s tissue. •• Do not use high intensity illumination in cavities with small lumens. •• Do not use high intensity illumination when the distal end of the endoscope is placed into close proximity to the tissue. •• If the distal end is soiled and impairs proper visualization, remove the endoscope and clean the distal end. CAUTION Risk of injury to the user The light-guide connector on the endoscope becomes hot. There is a risk of burns if the endoscope is held by hand for a longer period. •• Avoid touching the light-guide connector when holding the endoscope.

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After use

6 After use 6.1 Removal and disassembly 1. Switch off the light source. CAUTION Risk of injury to the user The connectors on the endoscope become hot. There is a risk of burns when touching the connectors. •• Let the endoscope cool down after use. 2. 3. 4. 5.

Disconnect the light-guide cable from the light source. Disconnect the light-guide cable from the telescope. If applicable, remove the adapters. If applicable, remove the camera head.

If force is required for disassembly, dispose of the product.

6.2 Preparation for reprocessing at the point of use WARNING Risk of injury to the patient and/or the medical personnel If instruments are left in dry condition for a longer period, heavy debris may dry to the instrument, leading to incrustations that may be difficult to remove. •• Do not leave used instruments overnight before reprocessing. •• Reprocess this product immediately after use. Immediately after use 1. Immediately after use, prepare reusable instruments for reprocessing as described in this section. 2. Remove heavy debris from the product by wiping with an appropriate, single-use lint-free cloth or sponge. 3. Separate telescopes from other instruments. 4. Bring the product to the reprocessing area.

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