Adapter connector leakage test Reprocessing Instructions

10-2021 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

Table of contents

Table of contents 1

1 Target group ...

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2 General information ... 2.1 Read the reprocessing instructions ... 2.2 Read the reprocessing instructions for use ... 2.3 Read the instructions for use for the reprocessing unit ... 2.4 National laws and regulations ... 2.5 Additional information on the product ... 2.6 Description of warning messages ...

5 5 5 5 5 5 5

3 Safety ... 3.1 Unsterile product ... 3.2 Contaminated products ... 3.3 Working with process chemicals ... 3.4 Creutzfeldt-Jakob disease ...

7 7 7 7 7

4 Overview of processes ... 4.1 Reprocessing cycle for standard products ...

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5 Requisite materials ...

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6 Bedside Pre-Cleaning ... 10 6.1 Transport to the reprocessing site ... 10 7 Cleaning and disinfection ... 11 7.1 Reprocessing with automated decontamination ... 11 7.1.1 Automated cleaning: chemical disinfection ... 11 8 Visual inspection ... 12 9 Life span ... 13 9.1 Functional check ... 13 10 Packaging ... 14

NOT APPLICABLE FOR THE US Reprocessing instructions • Adapter connector leakage test • 13242XA_EN_V3.1_10-2021_RI_CE

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Target group

1 Target group These reprocessing instructions are intended for personnel with technical knowledge and expertise in the reprocessing of medical devices.

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General information

2 General information 2.1 Read the reprocessing instructions If the reprocessing instructions are not followed, patients, users, or third parties may be injured or the product may be damaged. Read the reprocessing instructions for the product and its components carefully and follow all the safety notes and warnings.

2.2 Read the reprocessing instructions for use If the reprocessing instructions for use are not followed, patients, users, or third parties may be injured or the product may be damaged. Read and follow the “Cleaning, disinfection, care, and sterilization of KARL STORZ instruments” instructions for use (item no. 96216003). The cleaning, disinfection, and sterilization procedures are explained in detail in the reprocessing instructions for use. The reprocessing instructions for use can be downloaded from www.karlstorz.com.

2.3 Read the instructions for use for the reprocessing unit If the instructions for use are not followed, patients, users, or third parties may be injured or the product may be damaged. Read the instructions for use for the reprocessing unit carefully and follow all the safety notes and warnings. Carry out reprocessing in accordance with the instructions for use for the reprocessing unit.

2.4 National laws and regulations National laws and regulations must be observed in addition to the accompanying documentation.

2.5 Additional information on the product Additional general information on the product can be requested and downloaded from www.karlstorz.com.

2.6 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

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General information

NOTICE NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

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Safety

3 Safety 3.1 Unsterile product The product is not sterile when delivered. The use of non-sterile products poses a risk of infection for patients, users, and third parties. Reprocess the product in line with the reprocessing instructions before initial use and every subsequent use.

3.2 Contaminated products During work on contaminated devices, the guidelines for personal safety must be observed.

3.3 Working with process chemicals Incorrect exposure time, concentration, life span, and range of action of chemicals can lead to a risk of infection for the patient, user, and third parties, as well as damage to the product. Note the information provided by the manufacturer of the chemicals and the microbiological range of action of the chemicals used.

3.4 Creutzfeldt-Jakob disease Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeld-Jakob disease has been diagnosed or is suspected: Dispose of the product properly and do not continue to use it.

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Overview of processes

4 Overview of processes The following reprocessing procedures have been approved for the product: –

Reprocessing with automated decontamination

A detailed description of the processes is provided in the respective chapters in these instructions.

4.1 Reprocessing cycle for standard products

Use

Purchasing

Storage Transport

Transport Precleaning Sterilization, release

Packaging

Decontamination Maintenance, functional test

Repair or disposal

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Requisite materials

5 Requisite materials The reprocessing accessories used must be clean and functional. The following reprocessing accessories are required: Application

Material

Initial treatment at the site of use

Moist compresses, possibly disposable cloth

Cleaning and disinfection Automated decontamination

Device with suitable slide-in trolley / instrument holder

Manual drying and/or after-drying

Medical compressed air from compressed air gun, item no. 27660 Alternatively: syringe 60 cc

Maintenance Packaging

Standardized and approved packaging

Suitable reprocessing accessories are listed in the following catalog: –

HYGIENE – Care, Sterilization, Storage Techniques (item no. 96211004)

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Bedside Pre-Cleaning

6 Bedside Pre-Cleaning Reprocessing of the product should start within 2 hours of use to ensure the effectiveness of the reprocessing processes listed in the reprocessing instructions. 1.

Wipe the surfaces of the product with a compress or disposable cloth to remove gross soiling, corrosive solutions, and drugs.

2.

Rinse surfaces with cold water.

3.

Rinse the lumens with a water-filled syringe.

6.1 Transport to the reprocessing site 1.

Right after using it, place the dry product in a suitable transport container.

2.

Transport the securely positioned product to the site of reprocessing.

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Cleaning and disinfection

7 Cleaning and disinfection The following procedures are validated and approved for cleaning and disinfection of the product: –

Automated cleaning: chemical disinfection

7.1 Reprocessing with automated decontamination 7.1.1 Automated cleaning: chemical disinfection A washer-disinfector for thermolabile devices must be used for the device. The washerdisinfector must meet the requirements of standard DIN EN ISO 15883 – Part 4. Required materials: –

Suitable slide-in trolley and, if necessary, suitable instrument holder. The selection must be made in consultation with the manufacturer of the AER.

1.

Place the device in the slide-in trolley and, if necessary, in the instrument holder.

2.

The parameters of the automated cleaning and disinfection process validated by KARL STORZ are specified in the document “Cleaning, Disinfection, Care, and Sterilization of KARL STORZ Instruments” (item no. 96216003).

Steps 1. Pre-irrigation 2. Cleaning 3. Intermediate irrigation 4. Chemical disinfection 5. Intermediate irrigation 6. Final irrigation 7. Drying WARNING Risk of infection due to residual liquid! If devices are not adequately dried following disinfection, the effectiveness of the validated reprocessing processes is not guaranteed. Use compressed air or a syringe filled with air to dry devices fully following disinfection. Check if the product is dry and dry it by hand if necessary, see chapter Visual inspection [p. 12].

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Visual inspection

8 Visual inspection 1.

Check products for the following points: ‒ Visible contamination ‒ Damage and corrosion ‒ Completeness ‒ Dryness

2.

Subject any products displaying visible soiling to another complete cleaning and disinfection process.

3.

Discard damaged and corroded medical devices.

4.

Discard incomplete medical devices or replace missing parts.

5.

Dry the product by hand if necessary.

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Life span

9 Life span The end of the product life is largely determined by wear, reprocessing processes, the chemicals used and any damage resulting from use.

9.1 Functional check If the device does not fulfill one of the points listed below or if damage can be identified, see chapter ‘Maintenance, repair, servicing and disposal’ in the instructions for use. The following tests must be carried out to detect functional limitations: 1.

Check the surface of the product for mechanical integrity and changes.

2.

Check the labeling for legibility.

3.

Check the product for mechanical integrity.

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Packaging

10 Packaging The packaging material must always be matched to the sterilization process being used. Required materials: –

Standardized packaging materials and packaging systems that are approved for the product (EN 868 Parts 2–10, EN ISO 11607 Parts 1 + 2, DIN 58953)

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