OES PRO TURis/TCRis Resectoscope HF-Resection Electrode 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... 8 2.1 Intended use... 8 2.2 Contraindications... 9 2.3 User qualification... 10 2.4 Environment of use... 10 2.5 General warnings and cautions... 10 3 Product description... 14 3.1 Scope of delivery... 14 3.2 HF-resection electrode... 14 3.3 Symbols... 16 3.4 Warranty... 17 4 Preparation... 18 4.1 Safety information for preparation... 18 4.2 Inspection... 18 4.3 Assembly and connection... 19 5 Use... 20 5.1 Safety information for use... 20 5.2 Using the electrosurgical generator ESG-400... 24 5.3 Vaporization of the prostate and intrauterine fibroids... 24 6 After use... 25 6.1 Disassembly... 25 6.2 Disposal... 25

7 Storage... 26 8 Repair, shipment and disposal... 27 8.1 Repair... 27 8.2 Shipment... 27 9 Compatible equipment... 28 10 Technical data... 32 10.1 General dimensions... 32 10.2 Specifications... 32 10.3 Ambient conditions... 32

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” (delivered with Olympus telescopes). • 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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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. <example> Bracketed terms refer to elements in the graphical user interface. Such elements can be: - buttons - menu items - dialog elements

1.4 Trademarks - STERRAD® - NXTM are trademarks of their respective owner.

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 6

General information 22045 Hamburg Germany

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Safety information

2 Safety information 2.1 Intended use 2.1.1 General intended use The electrodes are part of an instrument combination for resectoscopy in saline irrigation fluid. They are intended to be used with working elements, sheaths, HF-cable, 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 Urology - Transurethral diagnosis and treatment (resection, biopsy, vaporization, ablation, incision, cutting, enucleation) of the prostate - Transurethral diagnosis and treatment (resection, biopsy, vaporization, ablation, incision, cutting, enucleation) of bladder neck and bladder tumors - Treatment of bleedings in the lower urinary tract (coagulation) Gynecology - Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - Lysis of intrauterine septa - Endometrial ablation The following products are not allowed to be used in gynecology in Australia and Japan: WA22302S, WA22306S, WA22332S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22558S, WA22559S 8

Safety information

2.2 Contraindications 2.2.1 Urology 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. 2.2.2 Gynecology Absolute contraindications - Acute pelvic inflammatory disease Relative contraindications - Electrotherapeutical interventions are contraindicated, if, in the judgement 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. Hysteroscopy may be contraindicated by the following conditions, depending on the severity or extent: - Inability to distend the uterus - Cervical stenosis - Cervical/vaginal infection - Uterine bleeding or menses - Known pregnancy - Invasive carcinoma of the cervix 9

Safety information - Recent uterine perforation There are no known additional contraindications. 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 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.

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 Reusable products 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 winstructions for use of any product being used with this product. 10

Safety information 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. WARNING Risk of injury to the patient and 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 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 Using incompatible equipment can lead to injury of the patient and the user as well as damage to the product. • Only use compatible equipment as listed in the chapter “Compatible equipment” on page 28.

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Safety information 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. 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 and the user. • Before each use, observe the instructions in the section “Inspection” on page 18. • 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 can 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 unintended nerve stimulation. • Never try to bend the distal tip of the HF-resection electrode. CAUTION Risk of injury to the patient and the user Unintended current flow can cause injury to the patient and the user. • The patient must be insulated against all electrically conductive parts. Check that the patient does not come in contact with other metal parts (e.g., operating table) in any case. • Ground the operating table. • Place the patient on a dry, electrically insulating surface.

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Safety information • Prevent any contact between different skin surfaces (arms, legs) of the patient. Place dry gauze between the body and arms and between the legs to prevent such contact. • Prevent any skin contact between the patient and the user. CAUTION Risk of injury of 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” on page 8, “User qualification” on page 10 and “Environment of use” on page 10.

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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. WA22302S, WA22306S, WA22332S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22557S, WA22558S, WA22559S: - HF-resection electrode - 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 28. HF-resection electrodes are designed for the cutting, coagulation and vaporization of tissue in conductive irrigation fluid (Saline) using HF current. The shape of the distal tip is designed for a specific application (cutting, coagulation or vaporization). For detailed information on application, refer to the section “Applications of HF-resection electrodes” on page 16. The HF-resection electrode is a precise mechanical and electrical device which is very sensitive to mechanical and electrical stress.

1) Distal tip 2) Stabilizing tube 14

Product description 3.2.1 Color codes of HF-resection electrodes Size and application

1) Size Color code for size

Inner sheath

Outer sheath

Yellow

24 Fr.

26/27 Fr.

Grey

24/26/28 Fr.

26/27/28 Fr.

2) Application Color code for application

Type of application

Blue

Resection with saline solution

Compatibility

Color code for compatibility with telescope

Direction of view

Blue

12°

White

12°– 30°

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Product description 3.2.2 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. These devices are intended to be used in an irrigated environment. Use HF-resection electrodes only for compatible applications.

WA22503S

WA22507S

WA22521S

WA22523S

WA22537S

WA22538S

+

+

+

+

+

+

+

+

+

Cutting

+

+

+

–

+

+

+

+

+

+

–

Vaporization

–

–

–

–

–

–

–

–

–

–

–

WA22559S

WA22355S

+

WA22558S

WA22351S

+

WA22557S

WA22332S

Coagulation

WA22539S

WA22306S

compatible not compatible WA22302S

+ –

+

+

+

+

+

–

+

+

–

+

–

–

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

Keep away from rain. Keep dry

Batch code

Non-sterile

Quantity of content

Sterilized using ethylene oxide

Manufacturer

Do not reuse

Product description Symbol

Explanation

Symbol

Explanation

Date of manufacture

Indicates the stacking limit of a package by mass

Consult instructions for use

Storage conditions

Do not use if package is damaged

Transport conditions

Use by date

Indicates a recovery/recyclable package or package material

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

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

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

Do not resterilize

Green Dot-symbol for dual recycling system

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 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 and the user If the HF-resection electrode is not properly attached to the working element, sparkover can occur leading to electrical injury, thermal injury or 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.

4.2 Inspection Inspection of 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 and other defects on the insulation 18

Preparation - 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. 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.

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Use

5 Use 5.1 Safety information for use WARNING Risk of injury to the patient Using flammable liquids, flammable gases or other sources of ignition during the procedure can cause exogenous burns. • Do not use flammable liquids, flammable gases or other sources of ignition during the procedure. • Do not allow the medical device to come in contact with flammable liquids, flammable gases or other sources of ignition. WARNING Risk of injury to the patient During prolonged procedures, the combination of open blood vessels and certain pressure conditions can cause the irrigation fluid to be absorbed into the circulatory system creating a water intoxication condition called TUR syndrome or fluid overloadsyndrome. • Perform the resection with utmost care. CAUTION Risk of injury to the patient Gases that accumulate during TUR/is (Transurethral Resection) and TCR/is (Transcervical Endometrial Resection) are flammable. These gases can ascend into the roof of the bladder and the upper part of the uterus and can come in contact with the electrode. Activating the HF current while flammable gases are present can cause the gases to ignite or explode. This can result in bladder perforation or puncture, exogenous burns or other injury. • Do not activate the HF current while the distal end of the resectoscope is located in the accumulated gases or in their direct vicinity.

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Use • Evacuate or move the gases or allow the gases to escape from the bladder or uterus as necessary, before activating the HF current. CAUTION Risk of injury to the patient Using an insufficient flow rate can result in poor visibility of the field of view and can increase the temperature of the irrigation fluid. • Use a sufficient flow rate (minimum 300 ml/min). CAUTION Risk of injury to the patient There is a risk of injury if the temperature of the irrigation fluid reaches 43 °C/109 °F. • Do not preheat the irrigation fluid above body temperature (37 °C/99 °F). CAUTION Risk of injury to the patient Inserting instruments with non-conductive lubricant into the urethra during electrosurgical procedures can cause burns to the patient. • Only use conductive lubricants. CAUTION Risk of injury to the patient Some electrosurgical generators have a spray coagulation feature. Using the spray coagulation feature can cause sparkover leading to electrical injury, thermal injury or unintended nerve stimulation. • Do not use the spray coagulation feature. CAUTION Risk of injury to the patient and the user Accidentally activating HF current can cause injury to the patient and the user. • First position the instrument on the target area and then activate HF current. 21