SEALING CAP Instructions for Use

7 Repair, shipment and disposal... 27 7.1 Repair... 27 7.2 Shipment... 27 7.3 Disposal... 28 8 Technical data... 29 8.1 General dimensions... 29 8.2 Ambient conditions... 29

General information

1 General information 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. •• In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document. •• 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, 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.

1.3 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.

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General information This symbol indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2. 3. • 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 2) 3)

1.4 Trademarks -- STERRAD® -- NX™ are trademarks of their respective owner

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

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Safety information

2 Safety information 2.1 Intended use Sealing cap intended to be used with compatible instruments designed for endoscopic diagnosis and treatment.

2.2 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. Reprocessing Reprocessing may only be perfomed by qualified hygiene personnel.

2.3 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Reprocessing This product must be reprocessed according to the applicable national and local standards and regulations.

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Safety information

2.4 General dangers, 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 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. •• 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/or the user The use of damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings may cause infection, toxic shock and/or unintended nerve stimulation. •• Before each use, observe the instructions in the section “Inspection” on page 14 and “Maintenance” on page 25. •• Do not use damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings. •• Replace damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings. 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 sections “Intended use”, “User qualification“ and ”Environment of use”. 8

Safety information NOTICE Risk of damage to the product Exceeding the storage and transport conditions specified by Olympus may cause damage to the product. •• Only use, store and transport the product under the conditions specified in the section “Ambient conditions” on page 29.

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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. A0286, A0287, A0298, A0400: -- 6 sealing caps -- Instructions for use A0223, A0387, O0131, O0201: -- 10 sealing caps -- Instructions for use If the sealing caps are delivered in combination with instruments, the scope of delivery can include fewer sealing caps than specified above.

3.2 Sealing cap The sealing cap can be attached to the luer lock connector of the compatible equipment. The sealing cap prevents irrigation fluid from leaking out of the instrument. Compatible surgical instruments can be inserted through the sealing cap. A0223, O0201

1) Distal end 2) Proximal end 10

Product description A0387

1) Distal end 2) Proximal end A0400

1) Distal end 2) Proximal end

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

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Explanation

Symbol

Explanation

Catalog number ​

Indicates the range of humidity to which the medical device can be safely exposed

Batch code

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

Quantity of content

Indicates a recovery/recyclable package or package material

Product description Symbol

Explanation

Symbol

Explanation

Manufacturer

CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/ EEC

Date of manufacture

Green Dot-symbol for dual recycling system

Consult instructions for use

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

Storage conditions

Non-sterile

Transport conditions

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.

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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”. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section “Inspection”. •• Do not use a damaged product. 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.

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: -- no deformations -- no cracks -- no missing or loose parts •• Check all markings on the product for clear visibility.

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Preparation

4.3 Assembly and connection •• Attach the distal end of the sealing cap to the channel of the compatible instrument.

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After use

5 After use 5.1 Removal and disassembly If force is required to disassemble the product, dispose of the product.

5.2 Preparation for reprocessing at the point of use Immediately after use 1. Immediately after use, prepare reusable products for reprocessing as described in this section. 2. Remove heavy debris from the product by wiping with an appropriate, single-use lint-free cloth or sponge. 3. Bring the product to the reprocessing area. 5.2.1 Transport to the reprocessing area Transport in dry condition 1. Make sure that gross debris does not dry. 2. Contain the product during transport to avoid possible environmental or personnel contamination. 3. Reprocess the product according to the instructions in this document. Transport in wet condition 1. Make sure that the detergents or disinfectants do not cause protein fixation. 2. Contain the product during transport to avoid possible environmental or personnel contamination. 3. Reprocess the product according to the instructions in this document.

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Reprocessing

6 Reprocessing 6.1 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. WARNING Insufficient cleaning efficacy The cleaning efficacy may be compromised if the detergent fixes proteins to the product. •• Avoid any protein fixation prior to or during cleaning caused by the reprocessing process. WARNING Risk of injury to the patient and/or the medical personnel There is a risk of infection when using insufficient detergents. •• Only use detergents which have been validated for the product. CAUTION Risk of injury to the patient and/or the medical personnel Insufficient detergents or disinfectants can lead to protein fixation on the product. •• Preferably return the product from the point of use to the cleaning area in dry condition to avoid protein fixation caused by detergents or disinfectants. CAUTION Risk of injury to the patient High inflow temperatures during automated cleaning and disinfection can cause thermal coagulation of proteins.

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Reprocessing •• Make sure that the first water inflow into the washer-disinfector during automated cleaning and disinfection starts with cold temperatures (<20 °C or <68 °F) to avoid thermal coagulation of proteins. NOTICE Risk of damage to the product Detergents may contain various aggressive compounds which can damage the product. •• To remove residues, rinse the product thoroughly with deionized water as described by the manufacturer of the detergent. •• Do not use tap water for rinsing because it might be chlorinated. NOTICE Risk of damage to the product Incompatible detergents may considerably damage Olympus endoscopes and accessories. •• Use only solutions that are approved and verified (for example by FDA, DGHM or a comparable institution) and that are certified by their manufacturers as safe for endoscopic instrument cleaning and disinfection. •• Select the immersion time and the concentration of the solution in accordance with the instructions given by the manufacturer of the detergent.

6.2 General information for reprocessing Brand-new products Treat brand-new products as if they have been used. Brand-new products must be reprocessed using a complete reprocessing cycle. The reprocessing cycle •• Reprocess the product according to the instructions in this chapter.

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Reprocessing •• To minimize the risk of infecting patients, users or third parties, reprocess the product before each use. •• Contact your local hygiene representative for local standards and regulations. Manual cleaning or automated cleaning In general, this product can be cleaned manually or automatically with sufficient results. Manual cleaning methods involve infection risks for the personnel responsible for reprocessing. Automated methods reduce these risks and provide the advantage of standardized, reproducible and validated procedures. Therefore, Olympus recommends to generally prefer automated cleaning methods. Validated for efficacy Validated for efficacy means that the efficacy of the method or agent has been validated for reprocessing this product as described in this document. Verified for material compatibility Verified for material compatibility means that according to current knowledge the reprocessing method or agent does not negatively affect materials or functional performance of the product. Verified for material compatibility does not mean that microbiological efficacy can be guaranteed. 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. ++ + – o

Method validated for microbiological/cleaning efficacy and verified for material compatibility Method verified for material compatibility Incompatible Contact an Olympus representative for additional information 19

Reprocessing # / *

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Not tested Not applicable Only for “Preparation for automated cleaning”

Reprocessing Process

All products covered in this document

Preparation at the point of use

Deposition

Wet

#

Dry

Decontamination

Preparation

Selection according to the cleaning and disinfection procedures

#

Cleaning

Manual

Automated

Disinfection

Ultrasonic

#

Alkaline detergent

o

Acidic detergent

o

Neutral detergent

++

Alkaline detergent

++

Acidic detergent

o

Neutral detergent

o

Chemical

o

Thermal

++

Manual Automated

Rinsing

#

++

Drying (dry heat)

Tmax

Steam (preferred method)

Autoclave (prevacuum)

95 °C (203 °F) (max. 10 min)

Maintenance Sterilization

++

Low temperature: steam and formaldehyde

#

Ethylene oxide Gas Plasma

# STERRAD® 100S

#

STERRAD® NX™/100NX™

#

Preparing the product for reprocessing The equipment must be disassembled. For information on disassembly, refer to the chapter “After use” on page 16.

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Reprocessing Instructions for using detergents •• All components of the product must be completely immersed in the detergent. •• Select the immersion time, concentration and temperature of the solution in accordance with the instructions given by the manufacturer of the detergent. •• Make sure that there are no air bubbles. Instructions for using alcohol •• Refer to national and local guidelines regarding the approval of using alcohol.

6.3 Manual cleaning This section describes the manual cleaning of the product. Alternatively, automatically clean and disinfect the product as described in the section “Automated cleaning and disinfection” on page 23. 6.3.1 Manual cleaning procedure Manual cleaning of the product has been validated with the following detergent: -- Neodisher MediZym 0.5% manufactured by Chemische Fabrik Dr. Weigert GmbH und Co. KG 1. Immerse the product in enzyme-based detergent for at least 20 min. 2. Thoroughly rinse the product and the inner lumen at least 10 times with enzyme-based detergent using a syringe of at least 10 ml. 3. Thoroughly rinse the product with deionized water for at least 30 s using a syringe of at least 10 ml.

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Reprocessing

6.4 Automated cleaning and disinfection This section describes the automated cleaning and disinfection of the product. Alternatively, manually clean the product as described in the section “Manual cleaning” on page 22. Appropriate washer-disinfector with thermal disinfection programs •• Use only a washer-disinfector with thermal disinfection programs which are specifically intended for cleaning and disinfection of reusable medical instruments and accessories by the manufacturer. •• Use only a washer-disinfector with thermal disinfection programs in accordance with international standard series ISO 15883. •• Refer to the instructions for use of the washer-disinfector. •• For automated cleaning, use alkaline detergent. Detergents in automated cleaning •• Only use detergents which have been validated for the product. •• Select the immersion time, concentration and temperature of the solution in accordance with the instructions given by the manufacturer of the detergent. Automated cleaning of the product has been validated with the following detergents: -- Neodisher MediClean forte manufactured by Chemische Fabrik Dr. Weigert GmbH und Co. KG -- 0.5% solution -- pH value: approx. 10.3 -- Neodisher Z manufactured by Chemische Fabrik Dr. Weigert GmbH und Co. KG -- 0.1% solution -- pH value: approx. 1.2

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