Telescope Series Instructions for Use Rev 2.0 April 2013

8.2 8.3 8.4 8.5 8.6

General Information for Reprocessing... 35 Manual Cleaning... 38 Automated Cleaning and Disinfection... 40 Maintenance... 40 Sterilization... 41

9 Repair and Disposal... 44 9.1 Repair... 44 9.2 Disposal... 45 10 Compatible Equipment... 46 11 Technical Data... 52 11.1 General Dimensions... 52 11.2 Dimensions for Reprocessing... 52 11.3 Specifications... 54 11.4 Ambient Conditions... 54

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1 General Information 1.1 User Instructions The complete set of instructions for use for this product consists of the product-specific instructions for use (this document) and the system-related instructions for use “System Guide Endoscopy”. • Before use, thoroughly read these instructions for use, the “System Guide Endoscopy”, and the instructions for use of all other products that will be used during the procedure. • Use the instructions in this document if the instructions differ from the “System Guide Endoscopy”. • If the required 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.

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1.3 Conventions 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. 1. A numeration indicates a sequence of actions. 2. • 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 are trademarks of their respective owner.

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

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2 Safety Information 2.1 Intended Use Olympus telescopes are designed for the visualization of endoscopic diagnosis and treatment for the following applications. Telescope A70940A, A70941A, A70942A, A70960A, A70961A, A70962A, A70963A -- Endoscopic inspection and visualization of the treatment of joints (knees, shoulders, hips, feet, ankles, hands, wrists, and elbows) -- Laryngeal, pharyngeal and tracheal surgery -- Face lift procedures, thyroid and parathyroid surgery, head and neck surgery, biopsy taking procedures in ENT • Do not use for any other purposes. Telescope A7504A, A7505A, A7506A, A7507A -- Endoscopic inspection and visualization of the treatment of joints (knees, shoulders, hips, feet, ankles, hands, wrists, and elbows) -- Laryngeal, pharyngeal and tracheal surgery -- Face lift procedures, thyroid and parathyroid surgery, head and neck surgery, biopsy taking procedures in ENT • Do not use for any other purposes. Telescope WA96100A, WA96105A -- Laryngeal, pharyngeal and tracheal surgery

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8 Telescope WA96200A, WA96201A, WA96202A, WA96203A, WA96204A -- Sinus surgery, middle ear procedures, temporomandibular joint treatment, tonsils and adenoid treatment, OSAS (obstructive sleep apnea syndrome) treatment, including sleep endoscopy -- Face lift procedures, thyroid and parathyroid surgery, head and neck surgery, biopsy taking procedures in ENT Telescope WA96205A, WA96206A -- Laryngeal, pharyngeal and tracheal surgery -- Sinus surgery, middle ear procedures, temporomandibular joint treatment, tonsils and adenoid treatment, OSAS (obstructive sleep apnea syndrome) treatment, including sleep endoscopy -- Face lift procedures, thyroid and parathyroid surgery, head and neck surgery, biopsy taking procedures in ENT Handle WA96208A Handle for use with a compatible telescope.

2.2 Contraindications The intended use and contraindications of the equipment used in combination with the telescope must be observed.

2.3 User Qualification Medical use This product is only intended to be used by a trained physician or trained qualified medical personnel under the supervision of a physician. Telescope

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9 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.

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, in the “System Guide Endoscopy” or in the instructions for use of any product being used with this product.

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10 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. • Follow the dangers, warnings, cautions, and instructions in the “System Guide Endoscopy”. • In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document. 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” in this document. • Do not use a damaged product or a product with improper functioning. • Replace a damaged product or a product with improper functioning.

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11 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. • 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.

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12 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. • Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. • Contact your 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. • Only use compatible equipment as listed in the chapter “Compatible Equipment” in this document. 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. NOTICE Risk of damage to the endoscope A7504A, A7505A, A7506A, A7507A The endoscope is a precise optical device. Careless handling may damage the endoscope. • Always store and transport the endoscope in the supplied protective tube. • Remove the endoscope from the protective tube only before direct use, manual cleaning, automated cleaning and disinfection.

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3 Upon Delivery • Make sure that the shipping case contains all of the items listed below. • Contact an Olympus representative or an authorized service center if any items are missing or damaged. Contents A70940A, A70941A, A70942A, A70960A, A70961A, A70962A, A70963A -- Telescope (with eyepiece cup A5333, light-guide adapter O0332 and A0460) -- Instructions for use -- System Guide Endoscopy Contents A7504A, A7505A, A7506A, A7507A -- Telescope (with protective tube A0547, light-guide adapter O0332 and A0460) -- Instrument tray WA05990A -- Instructions for use -- System Guide Endoscopy Contents WA96100A, WA96105A -- Telescope (with handle) -- Instructions for use -- System Guide Endoscopy Contents WA96200A, WA96201A, WA96202A, WA96203A, WA96204A, WA96205A, WA96206A -- Telescope (with handle WA96208A) -- Instructions for use -- System Guide Endoscopy

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14 Contents WA96208A -- Handle -- Access information sheet

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4 Product Description 4.1 Telescope A telescope is a rigid endoscope. An image relay system transmits the endoscopic image. The image relay system consists of: -- rod lenses (A70940A, A70941A, A70942A, A70960A, A70961A, A70962A, A70963A, WA96100A, WA96105A, WA96200A, WA96201A, WA96202A, WA96203A, WA96204A, WA96205A, WA96206A) -- optical fibers (A7504A, A7505A, A7506A, A7507A) A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. Telescopes are precise optical devices which are very sensitive to mechanical impacts. Entire telescope

A70940A, A70941A, A70942A

A70960A, A70961A, A70962A, A70963A

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17 Main body A70940A, A70941A, A70942A, A70960A, A70961A, A70962A, A70963A

1) 2) 3) 4) 5) 6) 7) 8) 9)

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Insertion tube Locking cone Light-guide adapter A0460 Light-guide adapter O0332 Light-guide connector Eyepiece cup A5333 Color code Quick-lock connector Ocular thread

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18 Main body A7504A, A7505A, A7506A, A7507A

1) 2) 3) 4) 5) 6) 7) 8) 9)

Insertion tube Locking cone Light-guide adapter A0460 Light-guide adapter O0332 Light-guide connector Eyepiece cup A5333 Color code Quick-lock connector Ocular thread

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19 Main body WA96100A, WA96105A

1) 2) 3) 4) 5) 6) 7)

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Insertion tube Handle Color code Eyepiece cup Light-guide connector Light-guide adapter O0332 Light-guide adapter A0460

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20 Main body WA96200A, WA96201A, WA96202A, WA96203A, WA96204A, WA96205A, WA96206A

1) 2) 3) 4) 5) 6)

Insertion tube Light-guide adapter A0460 Light-guide adapter O0332 Light-guide connector Color code Eyepiece cup

Color code Green... 0° direction of view Red... 30° direction of view Blue... 45° direction of view Yellow... 70° direction of view Brown... 90° direction of view

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1) Objective cover glass 2) Light emission surface Eyepiece cup

1) Eyepiece cover glass

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4.2 Handle WA96208A

1) Distal end 2) Locking lever 3) Locking ring

4.3 Symbols This section gives an explanation for each symbol used on the product and on the packing of the product. Catalog number Serial number Quantity of content Manufacturer Date of manufacture

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

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

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

4.4 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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