Light Guide Cable 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... 7 2.1 Intended use... 7 2.2 Contraindications... 7 2.3 User qualification... 7 2.4 Environment of use... 8 2.5 General warnings and cautions... 8 3 Product description... 11 3.1 Scope of delivery... 11 3.2 Light-guide cable... 11 3.3 Symbols... 13 3.4 Warranty... 13 4 Preparation... 14 4.1 Safety information for preparation... 14 4.2 Inspection... 14 4.3 Assembly and connection... 15 5 Use... 17 5.1 Safety information for use... 17 6 After use... 19 6.1 Disassembly... 19 6.2 Preparation for reprocessing at the point of use... 19 7 Reprocessing... 21 7.1 Safety information for reprocessing... 21 7.2 General information for reprocessing... 21

7.3 Manual cleaning... 24 7.4 Manual disinfection... 24 7.5 Automated cleaning and disinfection... 25 7.6 Maintenance... 26 7.7 Sterilization... 26 8 Repair, shipment and disposal... 28 8.1 Repair... 28 8.2 Shipment... 28 8.3 Disposal... 29 9 Ordering information... 30 10 Compatible equipment... 31 11 Technical data... 33 11.1 General dimensions... 33 11.2 Dimensions for reprocessing... 33 11.3 Classification of ME equipment and ME systems... 34 11.4 Ambient conditions... 34

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”. •• 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.

5

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.

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

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

6

Safety information

2 Safety information 2.1 Intended use 2.1.1 General intended use Transmission of light energy from the light source to an endoscope. •• Do not use for any other purposes. 2.1.2 Specific intended use The light-guide cable is used to transmit light during endoscopic diagnosis and therapy. 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. High-intensity visible light is transmitted to the instrument through a bundle of optical fibers. •• Do not use for any other purposes.

2.2 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.

2.3 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.

7

Safety information Reprocessing Reprocessing of reusable products 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 dangers, 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 instructions for use of any product being used with this product. WARNING Risk of injury to the patient and/or the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury and/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.

8

Safety information WARNING Risk of injury to the patient and/or the user The use of a damaged product or of a product with improper functioning may cause an electric shock, mechanical injury, infection, and/or thermal injury. •• Before each use, observe the instructions in the section “Inspection” on page 14. •• 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 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 may be additive. •• Only use type F applied part endoscopic equipment. •• 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.

9

Safety information WARNING Risk of injury to the patient and/or the user There is a risk of injury to the patient and/or 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/or the user Using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product. •• For information on compatible equipment, refer to the chapter “Compatible equipment” on page 31. 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.

10

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. WA03300A, WA03310A -- Light-guide cable (with light-guide adapter) -- Instructions for use

3.2 Light-guide cable The light-guide cable includes a bundle of optical fibers as transmission medium to transmit light from a light source to an optical instrument. A bundle of optical fibers does not transmit UV radiation. The light-guide cable is equipped with a light-guide adapter for Olympus light sources with plug connection. Entire light-guide cable

1) Endoscope connector 2) Kink protection 11

Product description 3) Connector casing 4) Light source connector with light-guide adapter Endoscope connector

1) Light emission surface Light source connector with light-guide adapter

1) Cover glass (light admission surface)

12

Product description

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

Explanation

Symbol

Explanation

Catalog number ​

Indicates the temperature limits to which the medical device can be safely exposed

Batch code

Type CF applied part

Quantity of content

Storage conditions

Manufacturer

Transport conditions

Date of manufacture

Autoclavable

Consult instructions for use

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

Protection class according to IEC 60529: Protected against the effects of temporary immersion in water

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.

13

Preparation

4 Preparation 4.1 Safety information for preparation WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or 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 the chapter “Reprocessing” on page 21. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section “Inspection” on page 14. •• Do not use a damaged product. WARNING Risk of injury to the patient If the light-guide cable is not properly connected to the endoscope or the light source, the endoscopic image may suddenly disappear during the procedure. This may 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.

4.2 Inspection Inspection regarding reprocessing •• Make sure that the product has been properly reprocessed. •• Visually inspect the product thoroughly. The product must be visually clean. General inspection •• Check that the product has: 14

Preparation -- no dents, cracks, kinks, or deformations -- no cuts and other defects on the insulation of the cable -- no deep scratches -- no corrosion -- no lens damages or cover glass damages -- no missing or loose parts •• Check all markings on the product for clear visibility. Checking the light transmission •• Hold the endoscope connector of the light-guide cable against a lamp. •• Look into the endoscope connector of the light-guide cable. Black dots indicate defective light-guide fibers. •• Do not use a light-guide cable with more than 25 to 30% defective light-guide fibers. •• Replace the light-guide cable if the image appears too dark.

4.3 Assembly and connection If force is required to assemble the product, dispose of the product and use another one. 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 31. 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.

15

Preparation 4.3.1 Connecting the light-guide cable to the light source

•• Connect the light-guide cable to the light-guide connector. 4.3.2 Connecting the light-guide cable to the endoscope

•• Connect the light-guide cable to the light-guide connector.

16

Use

5 Use 5.1 Safety information for use WARNING Risk of injury to the patient There is a risk of an electric shock when the endoscopic equipment is inserted into the patient and the remote end of the light-guide cable comes in contact with the mains power. •• Always connect the endoscopic equipment before inserting the endoscope into the patient. CAUTION Risk of injury to the patient 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). •• 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.

17

Use CAUTION Risk of injury to the user 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.

18

After use

6 After use 6.1 Disassembly CAUTION Risk of injury to the user The connectors on the light-guide cable become hot. There is a risk of burns when touching the connectors. •• Let the light-guide cable cool down after use. NOTICE Risk of damage to the product A severe change in temperature of the hot light-guide cable may damage the product. •• Let the light-guide cable cool down after use. •• Do not use fluids to cool down the light-guide cable. NOTICE Risk of damage to the product Pulling on the cable may damage the product. •• Pull on the connector casing when disconnecting the lightguide cable from the light source. If force is required to disassemble the product, dispose of the product. 1. Switch off the light source. 2. Disconnect the light-guide cable from the light source. 3. If applicable, disconnect the light-guide cable from the endoscope. 4. If applicable, remove the light-guide adapters.

6.2 Preparation for reprocessing at the point of use •• Immediately after use, bring the product to the reprocessing area.

19

After use •• Reprocess the product according to the instructions in this document and the “System Guide Endoscopy”.

20

Reprocessing

7 Reprocessing 7.1 Safety information for reprocessing WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. •• Reprocess the product before first and each subsequent use. •• Reprocess the product according to the instructions in this chapter and the instructions in the “System Guide Endoscopy”. •• Use the reprocessing information in this document if the reprocessing information differs from the “System Guide Endoscopy”.

7.2 General information for reprocessing Compatible reprocessing methods (according to ISO 17664) The microbiological efficacy and/or material compatibility of the reprocessing methods listed in the table have been validated or verified with this product. For detailed information on validated reprocessing methods, refer to the instructions following the table. For detailed information on reprocessing methods, refer to the “System Guide Endoscopy”. ++ + – o

Method validated for microbiological efficacy and verified for material compatibility Method verified for material compatibility Incompatible Contact an Olympus representative for additional information

21