Ureteroscope Attachment Instructions for Use

CONTENTS 1 General Information... 5 1.1 User Instructions... 5 1.2 Signal Words... 5 1.3 Conventions... 6 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... 8 2.4 Environment of Use... 8 2.5 General Warnings and Cautions... 9 3 Upon Delivery... 12 4 Product Description... 14 4.1 Ureteroscope... 14 4.2 Attachment... 22 4.3 Symbols... 25 4.4 Warranty... 27 5 Preparation... 28 5.1 Safety Information for Preparation... 28 5.2 Inspection... 28 5.3 Assembly and Connection... 30 6 Use... 35 6.1 Safety Information for Use... 35 6.2 Inserting the Surgical Instrument ... 37 7 After Use... 40 8 Reprocessing... 41 8.1 Safety Information for Reprocessing... 41 W7092300

8.2 8.3 8.4 8.5 8.6

General Information for Reprocessing... 42 Manual Cleaning... 45 Automated Cleaning and Disinfection... 47 Maintenance... 49 Sterilization... 49

9 Repair and Disposal... 51 9.1 Repair... 51 9.2 Disposal... 52 10 Compatible Equipment... 53 11 Technical Data... 55 11.1 General Dimensions... 55 11.2 Dimensions for Reprocessing... 61 11.3 Specifications... 65 11.4 Classification of ME Equipment and ME Systems... 65 11.5 Ambient Conditions... 65

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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 Ureteroscope WA02943A, WA02944A, WA02946A, WA29040A, WA29040B, WA29041A, WA29041B, WA29042A, WA29042B, WA29048A, WA29048B, WA29049A, WA29049B Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures: -- Transurethral inspection of the ureters and the kidneys for diagnosis -- Transurethral insertion of catheters, guide wires, cannulas, forceps and electrodes into the urethra, the urinary bladder and the ureters -- Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from the urethra, the urinary bladder and the ureters -- Transurethral treatment and removal of tissue and stones from the ureters and the kidneys • Do not use for any other purposes. Attachment A0395, A0396, WA00395A, WA00396A Attachment for use in combination with a compatible ureteroscope for the following applications: -- Connection of the irrigation tubing -- Insertion of compatible instruments • 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 ureteroscope must be observed. W7092300

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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. 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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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 and/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. 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.

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10 • 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. • 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. W7092300

11 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.

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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 WA02943A, WA02944A, WA02946A -- Ureteroscope (with light-guide adapter O0332 and A0460) -- Instrument tray A5961 -- Instructions for use -- System Guide Endoscopy Contents WA29040A, WA29041A, WA29048A, WA29049A -- Ureteroscope -- Instrument tray A5961 -- Attachment WA00395A -- Sealing caps WA00387A -- Instructions for use -- System Guide Endoscopy Contents WA29040B, WA29041B, WA29048B, WA29049B -- Ureteroscope -- Instrument tray A5961 -- Attachment A0395 -- Sealing caps A0387 -- Instructions for use -- System Guide Endoscopy Contents WA29042A -- Ureteroscope -- Instrument tray A5961 -- Attachment WA00396A -- Sealing caps WA00387A W7092300

13 -- Instructions for use -- System Guide Endoscopy Contents WA29042B -- Ureteroscope -- Instrument tray A5961 -- Attachment A0396 -- Sealing caps A0387 -- Instructions for use -- System Guide Endoscopy Contents A0395, A0396 -- Attachment -- Sealing caps A0387 -- Access information sheet Contents WA00395A, WA00396A -- Attachment -- Access information sheet

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4 Product Description 4.1 Ureteroscope A semi-rigid endoscope designed for the visualization of diagnostic and therapeutic procedures. There are single-channel ureteroscopes and dual-channel ureteroscopes. An image relay system of fiber bundles transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. Ureteroscopes are precise optical devices which are very sensitive to mechanical impacts. Entire ureteroscope

WA02943A

WA02944A

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WA02946A

WA29040A, WA29040B

WA29041A, WA29041B

WA29042A, WA29042B

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WA29048A, WA29048B

WA29049A, WA29049B

4.1.1 Ureteroscope WA02943A

1) 2) 3) 4)

Insertion tube Light-guide adapter A0460 Light-guide adapter O0332 Light-guide connector W7092300

17 5) Eyepiece cup 6) Finger rest 7) Instrument/irrigation port 8) Instrument/irrigation port 9) Finger rest 10) Blue ring

4.1.2 Ureteroscope WA02944A, WA02946A

1) Insertion tube 2) Light-guide adapter A0460 3) Light-guide adapter O0332 4) Light-guide connector 5) Finger rest 6) Eyepiece cup 7) Instrument/irrigation port 8) Instrument/irrigation port 9) Finger rest 10) Blue ring

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4.1.3 Ureteroscope WA29040A, WA29040B, WA29041A, WA29041B, WA29042A, WA29042B

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

Insertion tube Light-guide connector Eyepiece cup Finger rest Locking ring Finger rest Blue ring

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4.1.4 Ureteroscope WA29048A, WA29048B, WA29049A, WA29049B

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

Insertion tube Light-guide connector Finger rest Eyepiece cup Locking ring Finger rest Blue ring

4.1.5 Distal End

1) Instrument channel W7092300

20 2) Objective cover glass 3) Light emission surface

4.1.6 Eyepiece Cup

1) Eyepiece cover glass

4.1.7 Light-Guide Connector

1) Light admission surface

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4.1.8 Direction of View and Minimum Instrument Channel Width WA02943A, WA02944A, WA02946A

-- The direction of view is indicated in degree under the eyepiece cup. -- The minimum instrument channel width is indicated in French on the instrument/irrigation port.

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