OES ELITE Telescopes Instructions for Use Rev 6 Jan 2017

Contents 1 General information... 5 1.1 User instructions... 5 1.2 Signal words... 5 1.3 Conventions throughout this document... 6 1.4 Trademarks... 6 1.5 Manufacturer... 6 2 Safety information... 7 2.1 Intended use... 7 2.2 Contraindications... 8 2.3 User qualification... 8 2.4 Environment of use... 8 2.5 General warnings and cautions... 9 3 Product description... 12 3.1 Scope of delivery... 12 3.2 Telescope... 12 3.3 Protective tube... 16 3.4 Symbols... 17 3.5 Warranty... 18 4 Preparation... 19 4.1 Safety information for preparation... 19 4.2 Inspection... 19 4.3 Assembly and connection... 21 5 Use... 23 5.1 Safety information for use... 23 5.2 Procedure... 24 6 After use... 25 6.1 Removal and disassembly... 25 6.2 Attaching the telescope to the protective tube... 25 6.3 Preparation for reprocessing at the point of use... 26

7 Reprocessing... 27 7.1 Safety information for reprocessing... 27 7.2 General information for reprocessing... 28 7.3 Manual cleaning... 31 7.4 Manual disinfection... 33 7.5 Automated cleaning and disinfection... 33 7.6 Maintenance... 34 7.7 Sterilization... 34 8 Repair, shipment and disposal... 39 8.1 Repair... 39 8.2 Shipment... 39 8.3 Disposal... 40 9 Compatible equipment... 41 10 Technical data... 45 10.1 General dimensions... 45 10.2 Dimensions for reprocessing... 46 10.3 Specifications... 46 10.4 Ambient conditions... 46

General information

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 the HF equipment 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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General information

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. •• 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 Olympus telescopes are designed for the visualization of endoscopic diagnosis and treatment in the following fields of application: -- Urology -- Gynecology -- Otorhinolaryngology Telescope WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA In urology: -- Cystoscopy -- Resectoscopy -- Urethrotomy In gynecology: -- Hysteroscopy -- Resectoscopy In otorhinolaryngology: -- Laryngeal, pharyngeal and tracheal surgery •• Do not use for any other purposes. Telescope WA2T412P, WA2T430P, WA2T470P In urology: -- Photodynamic diagnosis (PDD) -- Cystoscopy -- Resectoscopy •• Do not use for any other purposes. Protective tube WA2P400A Protective tube to protect OES ELITE telescopes during transport, storage and steam sterilization. 7

Safety information •• Do not use for any other purposes.

2.2 Contraindications There are no known 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. 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.

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Safety information

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. 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” on page 19. •• Do not use a damaged product or a product with improper functioning. •• Replace a damaged product or a product with improper functioning. 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 type F applied part endoscopic equipment.

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Safety information •• 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. 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.

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Safety 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 41. CAUTION Risk of injury to the user There is a risk of injury to the user when using endoscopic equipment in combination with laser equipment. •• Use suitable protection measures (e.g., filters, protective goggles). 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. •• Always store and transport the endoscope in the supplied protective tube. •• Remove the endoscope from the protective tube only before direct use, manual cleaning or automated cleaning and disinfection.

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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. WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA: -- Telescope -- Protective tube WA2P400A -- Instructions for use -- System Guide Endoscopy WA2T412P, WA2T430P, WA2T470P: -- Telescope (with light-guide adapter A0460) -- Protective tube WA2P400A -- Instructions for use -- System Guide Endoscopy WA2P400A: -- Protective tube -- Access information sheet

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. A PDD telescope is designed for endoscopic diagnosis, especially photodynamic diagnosis (PDD). A filter exclusively designed for PDD is built into the telescope. Light of suitable wavelength passes through the filter and enhances visualization. Telescopes are precise optical devices which are very sensitive to mechanical impacts.

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Product description For information on compatibility, refer to the chapter “Compatible equipment” on page 41. 3.2.1 Telescope WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA Entire telescope

Main body

1) 2) 3) 4)

Insertion tube Connector pin Light-guide connector Color code Green: 0° direction of view Blue: 12° direction of view Red: 30° direction of view Yellow: 70° direction of view 5) Eyepiece cup

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Product description 3.2.2 PDD telescope WA2T412P, WA2T430P, WA2T470P Entire telescope

Main body

1) 2) 3) 4) 5)

Insertion tube Connector pin Light-guide adapter A0460 Light-guide connector Color code Blue: 12° direction of view Red: 30° direction of view Yellow: 70° direction of view Purple: for use in photodynamic diagnosis (PDD) 6) Eyepiece cup

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Product description 3.2.3 Distal end

1) Objective cover glass 2) Light emission surface 3.2.4 Eyepiece cup

1) Eyepiece cover glass

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Product description 3.2.5 Direction of view

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

3.3 Protective tube The protective tube is a rigid tubular device that protects the telescope from mechanical stress during transport, storage and steam sterilization. It is made of a polymer material. The dimensions of the protective tube are harmonized with the dimensions of the respective compatible telescope to cover the fragile parts of the telescope. The protective tube features a connecting mechanism to ensure a reliable connection to the compatible telescope. For information on compatibility, refer to the chapter “Compatible equipment” on page 41.

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Product description WA2P400A

1) Distal end 2) Clamping piece 3) Proximal end

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

Explanation

Symbol

Explanation

Catalog number

Autoclavable

Serial number

In combination with a high resolution camera head and monitor a high resolution image can be displayed

Quantity of content

Storage conditions

Manufacturer

Transport conditions

Date of manufacture

Green Dot-symbol for dual recycling system

Caution, consult accompanying documents

Indicates a recovery/recyclable package or package material

Consult instructions for use

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

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Product description Symbol

Explanation

Symbol

Explanation

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

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

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

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

3.5 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 27. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section “Inspection” on page 19. •• 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. Checking the image quality •• Hold a piece of writing at approximately 15 mm from the objective cover glass. •• Only use the telescope if the writing is clearly visible through the telescope. 20

Preparation •• Check that the image is not cloudy, out of focus or dark. General inspection of the protective tube •• Check all markings on the product for clear visibility.

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 Removing the telescope from the protective tube

•• Remove the telescope from the protective tube. Do not use excessive force. 4.3.2 Selecting compatible system components •• Refer to the chapter “Compatible equipment” on page 41 to identify the compatible system components. •• Observe the instructions for use of the compatible system components.

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