HF-Resection Electrode and HF cables for TURi Resectoscops 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... 8 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 HF-resection electrode... 11 3.3 HF cable... 14 3.4 Symbols... 16 3.5 Warranty... 17 4 Preparation... 18 4.1 Safety information for preparation... 18 4.2 Inspection... 19 4.3 Assembly and connection... 19 5 Use... 24 5.1 Safety information for use... 24 5.2 General information for use... 28 5.3 Vaporization of the prostate... 29 6 After use... 30 6.1 Disassembly... 30 6.2 Disposal... 30

7 Storage... 31 8 Repair and shipment... 32 8.1 Repair... 32 8.2 Shipment... 32 9 Compatible equipment... 33 10 Technical data... 37 10.1 General dimensions... 37 10.2 Specifications... 37 10.3 Ambient conditions... 37

General information

1 General information 1.1 User instructions • Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. • 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, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can 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.

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General 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. [example] Bracketed terms refer to elements in the graphical user interface or keys. Elements in the graphical user interface can be: - buttons - menu items - dialog elements

1.4 Trademarks - PlasmaKinetic™ is a trademarks of its 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 2.1.1 General intended use The electrodes with HF cable are part of an instrument combination for resectoscopy in saline irrigation fluid. They are intended to be used with working elements, sheaths, irrigation rings and a telescope in various diagnostic and therapeutical procedures involving the ablation and removal of soft tissue and hemostasis. 2.1.2 Specific intended use - Transurethral diagnosis and treatment (resection, biopsy, vaporization, ablation, incision, cutting, enucleation, coagulation) of the prostate - Transurethral diagnosis and treatment (resection, biopsy, vaporization, ablation, incision, cutting, enucleation, coagulation) of bladder neck and bladder tumors - Treatment of bleedings in the lower urinary tract (coagulation)

2.2 Contraindications Absolute contraindications There are no absolute contraindications. Relative contraindications - Electrotherapeutical interventions are contraindicated, if, in the judgment of the physician, tissue resection, vaporization, ablation, incision, cutting and coagulation could have a negative effect on the state of the patient. - Electrosurgical treatment of tissue may be contraindicated for patients with cardiac pacemakers, weakened immune systems or blood coagulation disorders. 7

Safety information

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.

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment.

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 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 The product is for single use only and delivered in a sterile condition. Reuse, reprocessing or resterilization can lead to malfunction of the product and injury of the patient. • Do not use sterile-packaged products if the packaging has been opened, is damaged or if there are other signs of nonsterility. • Do not use the product after its expiration date. • Open the packaging only immediately before use. • Do not attempt to reprocess or resterilize single-use products. • Do not reuse single-use products.

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Safety information WARNING Risk of injury to the patient and the user There is a risk of injury to the patient and the user caused by unauthorized repairs and product modification. • Do not attempt to repair or modify the product. CAUTION Risk of injury to the patient and the user An insufficient understanding of the 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. CAUTION 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 patient and the user Using incompatible equipment can lead to injury of the patient and the user. • Only use compatible equipment as listed in the chapter “Compatible equipment” on page 33. CAUTION 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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Safety information CAUTION Risk of injury to the patient and the user Using damaged equipment, equipment that does not function properly or equipment with illegible or missing markings can lead to injury of the patient. • Before each use, observe the instructions in the section “Inspection” on page 19. • Do not use damaged equipment, equipment that does not function properly or equipment with illegible or missing markings. • Replace damaged equipment, equipment that does not function properly or equipment with illegible or missing markings. • If signs of wear become visible during the procedure, replace the product. CAUTION Risk of injury to the patient Bending the distal tip may damage the HF-resection electrode leading to sparkover between the HF-resection electrode and the telescope. There is a risk of electrical, mechanical and thermal injury and/or unintended nerve stimulation. • Never try to bend the distal tip of the HF-resection electrode. CAUTION Risk of injury to the patient Laying the HF cable in loops can lead to mechanical injury. • To prevent tripping hazards, do not lay the HF cable in loops. • Use only plastic clips, hook fasteners and loop fasteners to fix HF cables to surgical drapes.

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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. WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, WA22639S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S, WA22651S, WA22655S, WA22657S, WA22666S, WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22751S, WA22755S, WA22760S, WA22766S: - 5 HF-resection electrodes - 5 HF cables - Instructions for use

3.2 HF-resection electrode The HF-resection electrode is a component of the resectoscope system. For information on compatibility, refer to the chapter “Compatible equipment” on page 33. HF-resection electrodes are designed for the cutting, coagulation and/or vaporization of tissue in conductive irrigation fluid (Saline) using HF current. The shape of the distal tip is designed for a specific application. For detailed information on the specific applications of the HF‑resection electrodes, refer to the section “Applications of HFresection electrodes” on page 13. The HF-resection electrode is for single use only and delivered in a sterile condition.

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Product description 3.2.1 Entire HF-resection electrode

1) Distal tip 2) Stabilizing tube 3.2.2 Color codes of HF-resection electrodes Color code for size and color code for application

1) Size Color code for size

Inner sheath

Outer sheath

Yellow

24 Fr.

26/27 Fr.

2) Application

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Color code for application

Type of application

Blue

Resection with saline solution

Product description Color code for compatibility with telescope

Color code for compatibility with telescope

Direction of view

Blue

12°/16°

White

12° - 30°

3.2.3 Applications of HF-resection electrodes HF-resection electrodes are classified according to their compatibility with coagulation, cutting, or vaporization. Refer to the table for compatible applications of the selected HF-resection electrode. + –

compatible not compatible

Article number

Coagulation

Cutting

Vaporization

WA22602S

+

+

–

WA22603S

+

+

–

WA22605S

+

+

–

WA22606S

+

+

–

WA22607S

+

+

–

WA22621S

+

+

–

WA22623S

+

+

–

WA22632S

+

+

–

WA22637S

+

+

–

WA22638S

+

–

–

WA22639S

+

+

–

WA22640S

+

+

–

13

Product description Article number

Coagulation

Cutting

Vaporization

WA22641S

+

–

+

WA22642S

+

+

–

WA22643S

+

+

–

WA22644S

+

+

–

WA22651S

+

–

–

WA22655S

+

+

–

WA22657S

+

–

+

WA22666S

+

–

+

WA22702S

+

+

–

WA22703S

+

+

–

WA22705S

+

+

–

WA22706S

+

+

–

WA22707S

+

+

–

WA22721S

+

+

–

WA22723S

+

+

–

WA22732S

+

+

–

WA22737S

+

+

–

WA22738S

+

–

–

WA22739S

+

+

–

WA22740S

+

+

–

WA22741S

+

–

+

WA22742S

+

+

–

WA22743S

+

+

–

WA22744S

+

+

–

WA22751S

+

–

–

WA22755S

+

+

–

WA22760S

+

–

+

WA22766S

+

–

+

3.3 HF cable The HF cable connects the electrosurgical generator to the instrument to supply HF current.

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Product description The HF cables are for single use only and delivered in a sterile condition. 3.3.1 HF cable for the electrosurgical generator PlasmaKinetic™ SuperPulse This section applies only to the following products: WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, WA22639S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S, WA22651S, WA22655S, WA22657S, WA22666S

1) Right angle plug, for working element 2) Straight plug, for working element 3) Plug (male), for electrosurgical generator 3.3.2 HF cable for the electrosurgical generator ESG-400 This section applies only to the following products: WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22751S, WA22755S, WA22760S, WA22766S

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Product description

1) Right angle plug, for working element 2) Straight plug, for working element 3) Plug (male), for electrosurgical generator

3.4 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 ​

Keep away from rain. Keep dry

Batch code

Sterilized using ethylene oxide

Quantity of content

Do not reuse

Manufacturer

Do not resterilize

Consult instructions for use

Do not use if package is damaged

Use by date

Indicates the stacking limit of a package by mass

Storage conditions

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

Product description Symbol

Explanation

Symbol

Explanation

Transport conditions

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

Indicates a medical device that needs protection from heat/ sunlight and radioactive sources

Green Dot-symbol for dual recycling system

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

Indicates a recovery/recyclable package or package material

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

Field of application: Urology

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 Connecting the irrigation tubing to non-endoscopic patient connections (e.g. intravenous accesses) can cause the irrigation fluid to be absorbed into the circulatory system. • Connect the irrigation tubing only to the resectoscope. CAUTION Risk of injury to the patient Improperly assembled equipment can cause sparkover, infection, electrical, mechanical and thermal injury and unintended nerve stimulation. • Observe the assembly instructions in these instructions for use and the instructions for use of all other products that will be used during the procedure. • When attaching the HF-resection electrode to the working element, check that the HF-resection electrode clicks audibly into position. • Check that the electrode is attached and positioned as described in the section “Assembly and connection” on page 19. CAUTION Risk of injury to the patient and the user Accidentally disconnecting the HF cable can cause sparkover leading to electrical injury, thermal injury or unintended nerve stimulation. • Check that the HF cable is securely connected to the instrument and the electrosurgical generator.

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Preparation

4.2 Inspection Inspection of the sterile packaging • Visually inspect the packaging thoroughly: - The packaging must not be open. - The packaging must not be damaged. - The packaging must have no other signs of non-sterility. General inspection • Check that the product has: - no dents, cracks, bending, or deformations - no cuts - no defects on the insulation - no scratches - no corrosion - no missing or loose parts • Check all markings on the product for clear visibility. Checking the function of the working element • Operate the handle. The working element must move smoothly.

4.3 Assembly and connection Attaching the HF-resection electrode to the working element • Refer to the instructions for use of the working element. Checking the attachment of the HF-resection electrode 1. Grasp the HF-resection electrode at the stabilizing tube. 2. Pull gently in distal direction. The HF-resection electrode must be properly attached.

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Preparation Checking the position of the HF-resection electrode

• Check that the distance between the telescope and the noninsulated distal tip of the HF-resection electrode is at least 2 mm. • If the distance is not at least 2 mm, replace the HF-resection electrode. 4.3.1 Connecting the HF cable to the instrument

1. Connect the right angle plug of the HF cable to the respective HF connector of the working element. 2. Connect the straight connector of the HF cable to the respective HF connector of the working element. 4.3.2 Connecting the HF cable to the electrosurgical generator PlasmaKinetic™ SuperPulse This section applies only to the following products: 20

Preparation WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, WA22639S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S, WA22651S, WA22655S, WA22657S, WA22666S • Refer to the instructions for use of the electrosurgical generator. • Insert the plug into the electrosurgical generator. Automatic presettings The electrosurgical generator PlasmaKinetic™ SuperPulse automatically recognizes the HF-resection electrode and applies appropriate presettings: Instrument name: [PK/TURis] - Mode: [TP2] - Power 180 W - Mode: [DES] - Power 100 W • Check that the correct instrument name [PK/TURis] appears on the display. • If the correct setting is not displayed, disconnect the plug and try again. If the correct setting is not displayed, do not use the product. • If necessary, adjust the settings to the procedure and the required tissue effects. 4.3.3 Connecting the HF cable to the electrosurgical generator ESG-400 This section applies only to the following products: WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22751S, WA22755S, WA22760S, WA22766S

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