OES PRO, TCRis HF-Resection Electrode, HF Cable Instructions for Use

Contents 1 Using this document... 5 1.1 User instructions... 5 1.2 Conventions throughout this document... 5 1.3 Safety-related information in this document... 6 2 Safety information... 8 2.1 Intended purpose... 8 2.2 Contact... 10 2.3 General safety notes... 10 3 Product description... 13 3.1 Scope of delivery... 13 3.2 Product functions... 13 3.3 Operating elements... 14 3.4 Symbols... 17 3.5 Warranty... 18 4 Before use... 19 4.1 Inspection... 19 4.2 Assembly and connection... 20 5 Use... 24 5.1 Safety notes for use... 24 5.2 Using the product... 29 6 After use... 31 6.1 Disassembly... 31 6.2 Disposal... 32 7 Repair, shipment and disposal... 33 7.1 Repair... 33 7.2 Shipment... 33

8 Ordering information... 34 9 Compatible equipment... 35 10 Technical data... 37 10.1 Electrical properties... 37 10.2 Ambient conditions... 37 11 Glossary... 38 12 Index... 40

Using this document

1 Using this document This chapter provides a general information on how to use these instructions for use.

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 Conventions throughout this document Convention Explanation 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. 3. ● Bullet points indicate individual actions. – Dashes indicate the listing of data, options or objects. – – 1) Numbers with right parenthesis name elements in illustrations. 2) 3) 5

Using this document

1.3 Safety-related information in this document For safe and efficient use of this product it is important to read the complete instructions for use. The safety related information of these instructions for use is not only described in this chapter. All information and instructions in this document are to ensure a safe and efficient use. Safety information are described in 3 categories: – General safety notes – Specific safety notes – Safety messages 1.3.1 General safety notes General safety notes are located at the beginning of the instructions for use. They address safety issues that apply to the general use and handling of the product. 1.3.2 Specific safety notes Specific safety notes are located at the beginning of a chapter or section. They address safety issues that are specific to the information and actions described in the chapter or section. 1.3.3 Safety messages Safety messages focus on unexpected incidents that can occur during the intended use. They are placed in the context of such risks and actions. The safety messages are highlighted by a signal word. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury.

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Using this document CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury.

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Safety information

2 Safety information This chapter provides general safety information for using the product. The safety information includes: – Intended purpose – Manufacturer information – General safety notes

2.1 Intended purpose 2.1.1 Intended use and indications Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications – 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 2.1.2 Contraindications – Acute pelvic inflammatory disease – 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.

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Safety information – 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 their severity or extent: – Inability to distend the uterus – Cervical stenosis – Cervical/vaginal infection – Uterine bleeding or menses – Known pregnancy – Invasive carcinoma of the cervix – 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. 2.1.3 Intended user Medical use Only for use by a qualified physician in an adequate medical environment. 2.1.4 Patient target group Adults: ≥ 18 years of age 2.1.5 Clinical benefits The HF-resection electrodes as a part of a bipolar hysteroresectoscope offer: – Removal and incision of uterine tissue – Transcervical access through a natural orifice, which is less invasive than open or laparoscopic surgery. – Lower risk of electrolyte imbalance (hyponatremia) compared to monopolar hysteroresectoscopes. 9

Safety information

2.2 Contact 2.2.1 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany Country-specific information Refer to the contact information for customers included in the scope of delivery for country-specific information. 2.2.2 Incident reporting If a serious incident occurs with the device, report it to the manufacturer and/or the relevant national authority according to national legislation.

2.3 General safety notes The following safety information addresses points that apply to the general handling and use of the product. This information is to be supplemented by the information given in each chapter of this document. WARNING Risk of injury to the patient Using flammable liquids, flammable gases or other sources of ignition during the procedure may 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.

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Safety information CAUTION 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. – 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”. 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 35. 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 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 This chapter provides a general overview of the product and its functions. This includes the following information: – Scope of delivery – Product functions – Operating elements – Explanation of symbols – Warranty information The HF-resection electrode and HF cable are for single use only and are delivered in a sterile condition.

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. Contents – 5 HF-resection electrodes – 5 HF cables – Instructions for use – Contact information for customers

3.2 Product functions 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. 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

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Product description Coagulation

Cutting

Vaporization

WA47705S

Catalog number

+

+

–

WA47706S

+

+

–

WA47707S

+

+

–

WA47721S

+

+

–

WA47723S

+

+

–

WA47732S

+

+

–

WA47737S

+

+

–

WA47738S

+

–

–

WA47739S

+

+

–

WA47740S

+

+

–

WA47741S

+

–

+

WA47742S

+

+

–

WA47743S

+

+

–

WA47744S

+

+

–

WA47751S

+

–

–

WA47755S

+

+

–

WA47760S

+

–

+

WA47766S

+

–

+

Duration of activation Do not exceed the maximum time of activation: Shape of distal tip

Maximum time of activation

Loop

2 min.

Button

10 min.

Roller

2 min.

Needle

2 min.

Band

2 min.

3.3 Operating elements This section shows all operating elements of the product and gives a brief description of the purpose of these elements.

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Product description HF-resection electrode

1) Distal tip 2) Stabilizing tube Color code for size and application

1) Size Color code for size

Inner sheath

Outer sheath

Yellow

24 Fr.

26/27 Fr.

2) Application Color code for application

Type of application

Blue

Resection with saline solution

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Product description Color code for compatibility with telescope

1) Color code Color code for compatibility with telescope

Direction of view

Blue

12°/16°

White

12° – 30°

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

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

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Product description

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

Explanation Batch code Quantity Catalog number Use-by date

Sterilized using ethylene oxide Do not use if package is damaged and consult instructions for use

Do not resterilize

Do not re-use

Consult instructions for use

Caution, consult accompanying documents

Manufacturer

Date of manufacture

CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation Transport conditions

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Product description Symbol

Explanation Storage conditions Temperature limit

Humidity limit

Keep dry

Protect from heat and from radioactive sources General symbol for recovery/recyclable

Green Dot symbol for dual recycling system

Stacking limit by mass

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

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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Before use

4 Before use This chapter describes all necessary steps to prepare the product for use.

4.1 Inspection Before connecting the product to the ancillary equipment, a thorough inspection ensures that the product is fit for use. A damaged product can cause an electric shock, mechanical injury, infection and thermal injury. 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 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. Inspection of the sterile packaging 1. Visually inspect the packaging: – The packaging must not be open. – The packaging must not be damaged. – The packaging must have no other signs of non-sterility. 2. If the packaging is opened, damaged or shows signs of nonsterility, do not use the product. Checking for mechanical defects 1. Check that the product has: 19

Before use – no dents, cracks, kinks, or deformations – no cuts – no defects on the insulation – no deep scratches – no corrosion – no missing or loose parts 2. Check all markings on the product for clear visibility. Replace if necessary If the instrument is damaged or does not function properly, replace it.

4.2 Assembly and connection 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. 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. Assembling the working element, telescope and HFresection electrode 1. Insert a compatible telescope into the telescope channel of the working element. Make sure that the connector pin clicks into position. 2. Select a compatible HF-resection electrode.

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Before use 3. Insert the proximal end of the HF-resection electrode into the distal opening of the electrode guiding tube of the working element. 4. Advance the HF-resection electrode into the working element until it comes to a stop. 5. Make sure that the telescope is guided through the stabilizing tube of the HF-resection electrode. Check that the HFresection electrode clicks audibly into position. Checking if the HF-resection electrode is properly attached

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

1. Check that the distance between the telescope and the noninsulated distal tip of the HF-resection electrode is at least 2 mm. 2. If the distance is not at least 2 mm, replace the HF-resection electrode.

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