LIGHT-GUIDE 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 1.4 Trademarks... 7 2 Safety information... 8 2.1 Intended purpose... 8 2.2 Contact... 9 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... 12 3.4 Symbols... 14 3.5 Warranty... 16 4 Before use... 17 4.1 Safety notes for preparation... 17 4.2 Inspection... 18 4.3 Assembly and connection... 19 5 Use... 21 5.1 Safety notes for use... 21 6 After use... 22 6.1 Disconnecting the light-guide cable... 22 6.2 Preparation for reprocessing at the point of use... 22 7 General information for reprocessing... 24 7.1 Overview of the reprocessing cycle... 25 7.2 Validated reprocessing methods... 27

8 Cleaning and disinfection... 29 8.1 Safety notes for cleaning and disinfection... 29 8.2 Manual cleaning... 30 8.3 Automated cleaning... 32 8.4 Inspection and maintenance... 35 9 Sterilization... 37 9.1 Safety notes for sterilization... 37 9.2 Selecting compatible sterilization methods... 38 9.3 Steam sterilization... 38 9.4 Hydrogen peroxide plasma sterilization (Sterrad)... 40 10 Repair, shipment and disposal... 41 10.1 Repair... 41 10.2 Shipment... 41 10.3 Disposal... 42 11 Ordering information... 43 12 Compatible equipment... 44 13 Technical data... 46 13.1 Dimensions... 46 13.2 Classification of ME equipment and ME systems... 46 13.3 Ambient conditions... 47 14 Glossary... 48 15 Index... 50

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. – – 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. NOTICE Indicates a property damage message.

1.4 Trademarks – Cidex® – neodisher® – NX™ – STERRA® – V-PRO® – One Step® 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 Transmission of light energy from the light source to an optical instrument. The light-guide cable is used to transmit light during endoscopic diagnosis and therapy or for other medical illumination application when the properties and operating instructions are complied with. The light-guide cable is designed for use with halogen, xenon or LED based light sources of cold light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes. High-intensity visible light is transmitted to the instrument through a bundle of optical fibers. 2.1.2 Contraindications There are no known contraindications. The intended use and contraindications of the equipment used in combination with the light-guide cable must be observed. 2.1.3 Patient target group Not dedicated to any specific patient population.

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Safety information 2.1.4 Intended user Medical use Only for use by a qualified physician or trained qualified medical personnel under the supervision of a 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. 2.1.5 Clinical benefits The device is used as part of a system. The clinical benefit of the device lies in its functionality as described by its intended purpose.

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.

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Safety 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 address 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 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. WARNING 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 18. ● Do not use a damaged product or a product with improper functioning. ● Replace a damaged product or a product with improper functioning.

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Safety information WARNING Risk of injury to the patient and the user There is a risk of an electric shock when using endoscopic equipment or when using endoscopic equipment in combination with energized endotherapy devices. The patient leakage currents can be additive. ● Before each use, check the applied part classification of the endoscopic equipment and especially the energized endotherapy devices used during the procedure. ● Only use endoscopic equipment or endoscopic equipment in combination with energized endotherapy devices that meet at least the same requirements of applied part classification. This is particularly important if a type CF applied part endoscope is used. In this case a type CF applied part energized endotherapy device should be used to minimize total leakage current. ● For the applied part classification, refer to the respective instructions for use. WARNING 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 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 44. NOTICE Risk of damage to the product Bending and coiling the light-guide cable may damage the product and may result in loss of transmission. ● Do not coil the light-guide cable into a diameter less than 15 cm (6 inches). ● Do not hang the light-guide cable on a hook. 11

Product description

3 Product description This section 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 products are delivered in unsterile condition. Reprocess the products 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. – 1 light-guide cable (with light-guide adapter WA03320A) – Instructions for use – Contact information for customers

3.2 Product functions The light-guide cable includes a bundle of optical fibers as transmission medium to transmit light from a light source to an optical instrument. The light-guide cable is equipped with a light-guide adapter for Olympus light sources with plug connection.

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 Entire light-guide cable

1) Endoscope connector For connecting the endoscope 2) Kink protection For protecting the light-guide cable against damage 3) Connector casing 4) Light source connector with light-guide adapter For connecting the light source Endoscope connector

1) Light emission surface

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Product description Light source connector with light-guide adapter

1) Cover glass (light admission surface) 2) Light-guide adapter WA03320A

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

Explanation Consult instructions for use

Caution, consult accompanying documents

Manufacturer Date of manufacture Batch code Quantity Catalog number

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Product description Symbol

Explanation Medical device Unique device identifier CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation Non-sterile

Type CF applied part

Protection class according to IEC 60529: Protected against the effects of temporary immersion in water Transport conditions Storage conditions Temperature limit

Humidity limit

General symbol for recovery/recyclable

Green Dot-symbol for dual recycling system

In accordance with European Directive on Waste Electrical and Electronic Equipment (WEEE), this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately Federal (USA) law restricts this device to sale by or on the order of a physician

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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 section describes all necessary steps to prepare the product for use.

4.1 Safety notes for preparation WARNING Risk of injury to the patient and the medical personnel Improper or incomplete reprocessing can cause infection of the patient and 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 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 18. ● Do not use a damaged product. WARNING Risk of injury to the patient and the user If the light-guide cable is not properly connected to the endoscope or the light source, the endoscopic image can suddenly disappear during the procedure. This can lead to mechanical injury to the patient. ● Properly connect the adapters to the light-guide cable and the endoscope. ● Properly connect the light-guide cable to the endoscope and the light source. CAUTION Risk of injury to the user and the patient There is a risk of damaging the eye when looking into the endoscope connector of the light-guide cable and the light source is switched on. ● Do not look into the endoscope connector of the light-guide cable when the light source is switched on. 17

Before use

4.2 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. Checking for mechanical defects 1. Check that the product has: – no dents, cracks, kinks, or deformations – no deep scratches – no corrosion – no lens damages or cover glass damages – 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. Checking the light transmission 1. Hold the light source connector of the light-guide cable against a lamp. 2. Look into the endoscope connector of the light-guide cable. Black dots indicate defective light-guide fibers. 3. Only use a light-guide cable if less than 25 to 30% of lightguide fibers are damaged. Replace the light-guide cable 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 This section describes all necessary steps to connect the lightguide cable to the light source and the endoscope. Refer to the chapter “Compatible equipment” on page 44 to identify the compatible light-guide adapter for the light source and the endoscope. 4.3.1 Selecting the correct light-guide adapter The light-guide cable is equipped with a light-guide adapter for Olympus light sources with plug connection. To use other lightguide adapters, proceed as follows: 1. Remove the light-guide adapter. 2. Select a light-guide adapter. Refer to the chapter “Compatible equipment” on page 44. 3. Attach the light-guide adapter to the light source connector of the light-guide cable. Refer to the respective instructions for use of the light-guide adapter. 4.3.2 Connecting the light-guide cable to the light source

● Connect the light-guide cable to the light source. 19

Before use 4.3.3 Connecting the light-guide cable to the endoscope

● Connect the light-guide cable to the light-guide connector of the endoscope.

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Use

5 Use This chapter describes safety information for use and provides information on how to use the product.

5.1 Safety notes for use WARNING Risk of injury to the patient and the user There is a risk of electric shock if the following conditions apply simultaneously: – The telescope is inserted in the patient. – The light-guide cable is connected to the telescope but not to the light source. – The light source connector of the light-guide cable comes in contact with a conductive surface. ● Completely connect the endoscope before inserting the endoscope into the patient. CAUTION Risk of injury to the patient and the user Light sources emit large amounts of energy. As a result the connectors of the endoscopic equipment and the distal end of the endoscope become hot. There is a risk of: – thermal injury to the patient’s tissue (e.g., from prolonged exposure to the intense illumination in cavities with small lumens, or if the distal end of the endoscope is placed into close proximity to the tissue). – burns to the patient’s or user’s skin. – burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials, etc.). ● Do not place the endoscopic equipment on the patient’s skin, on flammable materials, or on heat-sensitive materials. ● Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area. Avoid prolonged exposure to intense illumination. ● Switch off the light source or set the light source to standby mode whenever the light source is not in use. 21