LIGHT-CABLE CABLE and ADAPTERS 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... 13 3.1 Scope of delivery... 13 3.2 Product functions... 14 3.3 Operating elements... 14 3.4 Symbols... 18 3.5 Warranty... 19 4 Before use... 20 4.1 Safety notes for preparation... 20 4.2 Inspection... 21 4.3 Connecting the light-guide cable... 22 4.4 Connecting the light-guide adapter... 23 5 Use... 25 5.1 Safety notes for use... 25 6 After use... 27 6.1 Disconnecting the light-guide cable... 27 6.2 Preparation for reprocessing at the point of use... 27 7 General information for reprocessing... 29 7.1 Overview of the reprocessing cycle... 30 7.2 Validated reprocessing methods... 33

8 Cleaning and disinfection... 36 8.1 Safety notes for cleaning and disinfection... 36 8.2 Manual cleaning... 37 8.3 Manual disinfection... 39 8.4 Automated cleaning and thermal disinfection... 41 8.5 Inspection and maintenance... 44 9 Sterilization... 46 9.1 Safety notes for sterilization... 46 9.2 Selecting compatible sterilization methods... 47 9.3 Steam sterilization... 47 9.4 Hydrogen peroxide plasma sterilization (Sterrad)... 49 9.5 Vaporized hydrogen peroxide sterilization (Steris)... 50 10 Repair, shipment and disposal... 52 10.1 Repair... 52 10.2 Shipment... 52 10.3 Disposal... 53 11 Ordering information... 54 12 Compatible equipment... 55 13 Technical data... 59 13.1 Dimensions... 59 13.2 Classification of ME equipment and ME systems... 60 13.3 Ambient conditions... 60 14 Glossary... 62 15 Index... 65

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™ – STERRAD® – 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 A93200A Light-guide cables with fluid are intended for light transmission between light sources and endoscopes in photodynamic diagnosis (PDD). Do not use the product for any other purpose. A03203A, A0331, A0460, A0464, A3201, A3202, A3213, O0332, WA00331A, WA03021A, WA03022A, WA03023A Light-guide adapters are intended for the mechanical connection of light-guide cables to light sources or to endoscopes. Do not use the product for any other purpose. WA03320A This is a consumable component: it does not have a medical indented purpose. It is originally supplied as part of or together with the medical device. 2.1.2 Contraindications A93200A The light-guide cable A93200A is a type BF applied part and must not be used for procedures that contact the heart or the area near the heart. The light-guide cable A93200A must not be used in combination with devices that contact the heart or the area near the heart. 8

Safety information The intended use and contraindications of the equipment used in combination with the light-guide cable must be observed. A03203A, A0331, A0460, A0464, A3201, A3202, A3213, O0332, WA00331A, WA03021A, WA03022A, WA03023A, WA03320A 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. 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.

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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 European Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority. Eurasian Economic Union If an undesirable event occurs with the device, report it to the manufacturer or the authorized representative. Other regions If a serious incident occurs with the device, report it to the manufacturer and 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.

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Safety information 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 21. ● Do not use a damaged product or a product with improper functioning. ● Replace a damaged product or a product with improper functioning. 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. 11

Safety information 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 55.

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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. A93200A – 1 light-guide cable – Instructions for use – Contact information for customers A03203A, A0331, A0460, A0464, A3201, A3202, A3213, O0332, WA00331A, WA03021A, WA03022A, WA03023A – 1 light-guide adapter – Instructions for use – Contact information for customers WA03320A – 1 light-guide adapter – Access information sheet

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Product description

3.2 Product functions Light-guide cable Light-guide cables include a transmission medium to transmit light from one end of the light-guide cable to the other. Due to loss in transmission, the light output of a light-guide cable is only 1/3 of the input. The fluid-type light-guide cable A93200A contains non-toxic alkaline saline solution (pH 6 to 8) as transmission fluid and can be used for photodynamic diagnosis (PDD). Light-guide adapter There are 2 types of light-guide adapters: – Adapters for light sources – Adapters for endoscopes The adapters for light sources allow the light-guide cables to be connected to various Olympus light sources and light sources of other manufacturers. The adapters for endoscopes allow the light-guide cable to be connected to various Olympus endoscopes and endoscopes of other manufacturers.

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 3.3.1 Light-guide cable A93200A

1) 2) 3) 4)

Endoscope connector Kink protection Connector casing Light source connector

Endoscope connector

1) Light emission surface 15

Product description Light source connector

1) Cover glass (light admission surface) 3.3.2 Light-guide adapter A03203A, A0331, A0460, O0332, A0464, WA00331A, WA03023A

A03203A

A0331 A0460 O0332

A0464

WA00331A WA03023A

The screw-type adapters are screwed onto the light-connector of the endoscope.

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Product description WA03320A

WA03320A

A3201, A3202, A3213, WA03021A, WA03022A

A3201

A3202

A3213

WA03021A

WA03022A

The click-type adapters are clicked onto the endoscope connector of the light-guide cable.

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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 Consult instructions for use

Caution, consult accompanying documents

Manufacturer Date of manufacture Batch code Quantity Catalog number 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 BF applied part

Transport conditions Storage conditions Temperature limit

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Product description Symbol

Explanation 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

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 21. ● 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. 20

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, bending, or deformations – no cuts and other defects on the outer sleeve of the cable – no 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 – fluid-type cable A93200A 1. Connect the light-guide cable to the light source. 2. Switch on the light source. 3. Hold the endoscope connector of the light-guide cable against a thin, white cloth. 4. Only use the light-guide cable if the light transmission is satisfactory. Checking the light transmission – light-guide adapter 1. Hold the light source connector of the light-guide adapter against a lamp. 2. Look into the endoscope connector of the light-guide adapter. Black dots indicate defective light-guide fibers. 3. Only use a light-guide adapter if less than 25 to 30% of lightguide fibers are damaged. 21