SHEATH, STOPCOCK ACCESSORY 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 1.4 Trademarks... 7 2 Safety information... 8 2.1 Intended purpose... 8 2.2 Contact... 10 2.3 General safety notes... 10 3 Product description... 12 3.1 Scope of delivery... 12 3.2 Product functions... 12 3.3 Operating elements... 13 3.4 Symbols... 16 3.5 Warranty... 17 4 Before use... 18 4.1 Safety notes before use... 18 4.2 Inspection... 19 4.3 Assembly and connection... 20 5 Use... 23 5.1 Safety notes for use... 23 5.2 Inserting surgical instruments... 24 6 After use... 25 6.1 Disassembly... 25 6.2 Preparation for reprocessing at the point of use... 27 7 General information for reprocessing... 29 7.1 Overview of the reprocessing cycle... 29 7.2 Validated reprocessing methods... 32

8 Cleaning and disinfection... 34 8.1 Safety notes for cleaning and disinfection... 34 8.2 Manual cleaning... 35 8.3 Manual disinfection... 39 8.4 Automated cleaning and thermal disinfection... 42 8.5 Inspection... 46 9 Sterilization... 47 9.1 Safety notes for sterilization... 47 9.2 Steam sterilization... 47 10 Repair, shipment and disposal... 51 10.1 Repair... 51 10.2 Shipment... 52 10.3 Disposal... 52 11 Ordering information... 53 12 Compatible equipment... 54 13 Technical data... 55 13.1 Dimensions... 55 13.2 Ambient conditions... 56

Using this document

1 Using this document This chapter provides 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. – –

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Using this document 1) Numbers with right parenthesis name elements in illustrations. 2) 3) ► Arrows indicate the result of actions.

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.

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

1.4 Trademarks – STERRAD® – NX™ – V-PRO® are trademarks of their respective owner.

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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 WA47777A Hysteroscope sheath for endoscopic diagnosis and treatment in gynecologic applications. – transcervical diagnosis and treatment of abnormal uterine bleeding, endometrial polypectomy, submucous and intramural myoma, endometrial ablation, lost intrauterine devices, septa and synechiae – enabeling transcervical sterilization WA47778A Stopcock accessory to be used in combination with a compatible hysteroscope or ureteroscope. The stopcock has a sealing function, supports the insertion of semi-flexible and flexible instruments and supports the flow regulation of the irrigation fluid during gynecological or urological procedures. 2.1.2 Contraindications Absolute contraindications – Acute pelvic inflammatory disease

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Safety information 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 – Recent uterine perforation 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. 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.

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Safety information Otherwise, Olympus cannot be held responsible for the safety and performance of the product.

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 and the user An insufficient understanding of the warnings, cautions, and instructions can result in serious injury. ● Make sure to have the complete set of instructions for use.

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Safety information ● 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 and the user Using incompatible equipment an accessories can lead to injury of the patient and the user. ● Only use compatible equipment as listed in the chapter “Compatible equipment” on page 54. 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”, “User qualification” and “Environment of use”. NOTICE Risk of damage to the product If instruments touch each other during reprocessing, transport or storage, the instruments can be damaged. ● Avoid that instruments touch each other during reprocessing, transport or storage.

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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 product is delivered in unsterile condition. Reprocess the product before first and each subsequent use.

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. WA47777A – 1 Sheath – 1 Instructions for use – 1 Contact information for customers WA47778A – 1 Stopcock accessory – 1 Access information sheet – 1 Contact information for customers

3.2 Product functions The sheath is a rigid instrument. A telescope can be inserted into the telescope channel of the sheath from the proximal end to provide an endoscopic image during the procedure. The endoscopic image can be viewed using the ocular or by connecting a compatible camera head.

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Product description Compatible surgical instruments can be inserted into the instrument channel of the sheath. The irrigation stopcock can be used to control the inflow of the irrigation fluid. The instrument stopcock controls the passage of the surgical instruments. For information on compatibility, refer to the chapter “Compatible equipment” on page 54. As there is no outflow channel for the irrigation fluid, the irrigation fluid flows out between the sheath and the cervical canal.

3.3 Operating elements This section shows all operating elements of the product and gives a brief description of the purpose of these elements. 3.3.1 Sheath

1) 2) 3) 4)

Distal end Irrigation stopcock Irrigation port Instrument stopcock 13

Product description 5) Instrument channel 6) Telescope channel Irrigation stopcock The irrigation stopcock controls the inflow of the irrigation fluid. Depending on the desired inflow, the irrigation stopcock can be opened or closed. Instrument stopcock The instrument stopcock controls the passage of surgical instruments through the instrument channel. The stopcocks can be disassembled. If the components of the stopcocks are lost or damaged, replace them with a compatible stopcock accessory.

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Product description Stopcock open

Stopcock closed

3.3.2 Stopcock accessory

The stopcock accessory can replace the stopcocks of the sheath if the stopcock components are lost or damaged. For more information, refer to the chapter “Ordering information” on page 53. 15

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 Catalog number ​ Batch code Quantity of content Non-sterile

Consult instructions for use

Manufacturer

Date of manufacture

Storage conditions Transport conditions CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonisation legislation. Indicates a recovery/recyclable package or package material

Green Dot-symbol for dual recycling system

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

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Product description

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 each use.

4.1 Safety notes before use WARNING Risk of injury to the patient and the medical personnel Improper or incomplete reprocessing can cause infection of the patient. ● Reprocess the product before first and each subsequent use. ● For reprocessing the product, observe the instructions in this document. ● Do not use a product that has not been reprocessed. ● Before each use, inspect the product as described in the section “Inspection” on page 19. ● Do not use a damaged product. CAUTION Risk of injury to the patient and the user The use of a damaged product or of a product with improper functioning can cause an electric shock, mechanical injury, infection and thermal injury. ● 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.

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Before use

4.2 Inspection Before connecting the product to the ancilliary 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. Checking for mechanical defects 1. Check that the product has: – no dents, cracks, kinks, or deformations – no deep scratches – no corrosion – no missing or loose parts 2. Check all markings on the product for clear visibility. Checking for performed reprocessing 1. Make sure that the product has been properly reprocessed. 2. Visually inspect the product thoroughly. The product must be visually clean. 3. Only use the product if it is visually clean. Reprocess the product again if necessary. Replace if necessary If the product is damaged or does not function properly, replace it. Contact an authorized service center for repair.

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Before use

4.3 Assembly and connection 4.3.1 Assembling the stopcocks

1. Assemble the irrigation stopcock and the instrument stopcock. 2. Securely fasten the components of the stopcocks until they stop.

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Before use 4.3.2 Connecting the irrigation tubing

1. Close the irrigation stopcock. 2. Close the instrument stopcock. 3. Connect the irrigation tubing to the irrigation port. 4.3.3 Attaching the sealing cap ● Attach a sealing cap to the instrument channel. The compatible sealing cap must be ordered separately, for details refer to the chapter “Ordering information” on page 53.

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