ARTHROSCOPY TROCAR Instructions for Use

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... 7 2.3 User qualification... 7 2.4 Environment of use... 8 2.5 General dangers, warnings and cautions... 8 3 Product description... 11 3.1 Scope of delivery... 11 3.2 Arthroscopy trocar... 12 3.3 Symbols... 14 3.4 Warranty... 15 4 Preparation... 16 4.1 Safety information for preparation... 16 4.2 Inspection... 16 4.3 Assembly and connection... 17 5 Use... 20 5.1 Inserting the telescope... 20 5.2 Attaching the cover... 20 5.3 Performing irrigation... 21 5.4 Replacing the trocar tube during the procedure... 21 6 After use... 22 6.1 Disassembly... 22 6.2 Preparation for reprocessing at the point of use... 23

7 Reprocessing... 24 7.1 Safety information for reprocessing... 24 7.2 General information for reprocessing... 25 7.3 Manual cleaning... 27 7.4 Automated cleaning and disinfection... 28 7.5 Maintenance... 28 7.6 Sterilization... 31 8 Repair, shipment and disposal... 32 8.1 Repair... 32 8.2 Shipment... 32 8.3 Disposal... 33 9 Compatible equipment... 34 10 Technical data... 36 10.1 General dimensions... 36 10.2 Ambient conditions... 37

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 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. DANGER Indicates a hazardous situation which, if not avoided, will result in death or serious injury. 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® -- NX™ 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 Trocar tube for endoscopic diagnosis and treatment in arthroscopic applications. •• Do not use for any other purposes.

2.2 Contraindications Absolute contraindications -- spinal arthroscopy Relative contraindications There are no known relative contraindications related directly to the product. The intended use and contraindications of the equipment used in combination with the product 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 reusable products 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 specialized equipment. Reprocessing Reusable products must be reprocessed according to the applicable national and local standards and regulations.

2.5 General dangers, warnings and cautions The following dangers, 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 medical personnel The use of damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings may cause infection, toxic shock, electrical, mechanical and thermal injury and/or unintended nerve stimulation.

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Safety information •• Do not use damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings. WARNING Risk of injury to the patient and/or the medical personnel There is a risk of injury to the patient and/or the medical personnel due to malfunction of the equipment. •• Always have spare equipment available. WARNING Risk of injury to the patient and/or the medical personnel There is a risk of injury to the patient and/or the medical personnel caused by unauthorized repairs and product modification. Possible injuries include infection, toxic shock and mechanical injury. •• Do not attempt to repair or modify the product. WARNING Risk of injury to the patient Failure to observe the information given in the section “Intended use”, “User qualification” and “Environment of use” amounts to use of the product beyond the use for which it is intended. •• Observe the information given in the section “Intended use”, “User qualification” and “Environment of use”. CAUTION Risk of injury to the medical personnel Improperly assembled equipment may cause infection or mechanical injury. •• Follow the assembly instructions in this document. •• Follow the assembly instructions of all products that will be used during the procedure. 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.

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Safety information •• For information on compatible equipment, refer to the chapter “Compatible equipment” on page 34. If combinations are used that are not listed in this chapter, the user takes the full responsibility. NOTICE Risk of damage to the product Exceeding the storage and transport conditions specified by Olympus may cause damage to the product. •• Only store and transport the product under the conditions specified in the section “Ambient conditions” on page 37.

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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. A70950A, A70951A, A70970A, A70971A, WA70951B, WA70952A, WA70953A, WA70990A, WA70991A, WA70992A, WA70993A, WA70994A, WA70995A: -- Trocar tube -- Instructions for use A70954A, A70955A, A70974A, A70975A, A70978A, A7517, A7518, A7519, A7520, A70979A: -- Trocar spike -- Instructions for use A00507A: -- Sealing ring set -- Instructions for use

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Product description

3.2 Arthroscopy trocar 3.2.1 Trocar tube A70950A, A70951A, A70970A, A70971A, WA70951B, WA70952A, WA70953A, WA70990A, WA70991A, WA70992A, WA70993A, WA70994A, WA70995A

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

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Distal end Stopcock ring Stopcock Release button Locking ring Release knob for stopcock ring

Product description 3.2.2 Trocar spike A7517, A7518, A70954A, A70974A, A70978A

1) Distal end, triangular 2) Handle A7519, A7520, A70955A, A70975A, A70979A

1) Distal end, blunt 2) Handle 3.2.3 Cover A70959A

1) Locking cone 2) Handle

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Product description 3.2.4 Sealing ring A00507A

1) Flat side 2) Sealing lip

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

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Explanation

Symbol

Explanation

Catalog number ​

Consult instructions for use

Quantity of content

Storage conditions

Batch code

Transport conditions

Manufacturer Date of manufacture

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

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

Green Dot-symbol for dual recycling system

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

Product description

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 24. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section “Inspection” on page 16. •• Do not use a damaged product. WARNING Risk of injury to the reprocessing personnel Splashing of contaminated liquids may cause an infection of the reprocessing personnel. •• Reprocess the product with protective clothing and equipment only.

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. 4.2.1 General inspection •• Check that the product has: -- no dents, cracks, kinks, or deformations -- no deep scratches 16

Preparation -- no corrosion -- no missing or loose parts •• Check all markings on the product for clear visibility. 4.2.2 Specific inspection

•• Make sure that the trocar spike moves easily in the trocar tube. •• Make sure that the stopcock opens and closes smoothly. This section applies only to the following products: A7517, A7518, A70954A, A70974A, A70978A •• Make sure that the distal end of the trocar spike is sharp and free of damage.

4.3 Assembly and connection If force is required to assemble the product, dispose of the product and use another one.

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Preparation 4.3.1 Inserting the trocar spike

1. Insert a compatible trocar spike into the proximal opening of the trocar tube. 2. Press the trocar spike into the locking ring until it is securely fixed. 4.3.2 Connecting the irrigation tubing 1. Close all stopcocks.

2. Connect the inflow tube to the inflow port. This section applies only to the following products: A70951A, A70971A, WA70951B, WA70953A, WA70991A, WA70993A •• Connect the outflow tube to the outflow port.

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Preparation If the trocar tube starts to leak during the procedure, check the sealing rings. If the sealing rings have not been inserted correctly into the notch, remove the sealing rings and reinsert them as described in the chapter “Maintenance” on page 28.

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Use

5 Use 5.1 Inserting the telescope

•• Insert the telescope into proximal opening of the trocar tube. •• Make sure that the arrow on the telescope is aligned with the release button of the trocar tube.

5.2 Attaching the cover 1. Close the inflow stopcock. 2. Remove the telescope or trocar spike.

3. Press the locking cone of the cover into the locking ring of the trocar tube until it is securely fixed. 20

Use

5.3 Performing irrigation 1. 2. 3. 4.

Close the inflow stopcock. Remove the telescope or trocar spike. Attach the cover. Perform irrigation by alternately opening and closing the stopcocks.

5.4 Replacing the trocar tube during the procedure This section applies only to the following products: A70950A, A70951A, WA70951B, WA70952A, WA70953A If the trocar tube has to be replaced during the procedure, use a guiding rod (A70958A) to help regain access to the joint. 1. Close the inflow stopcock. 2. Remove the telescope or trocar spike. 3. Insert a guiding rod into the proximal opening of the trocar tube. 4. Remove the trocar tube from the patient. Make sure that the guiding rod remains inside the access to the joint. 5. Place a new trocar tube on the guiding rod inside the access to the joint. 6. Remove the guiding rod from the trocar tube.

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