BARANY Noise App. w. olive Reprocessing Instructions

02-2021 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 ... 4 2 General information... 5 2.1 Read the reprocessing instructions ... 5 2.2 Read the reprocessing instructions for use ... 5 2.3 Read the instructions for use for the reprocessing unit... 5 2.4 National laws and regulations... 5 2.5 Additional information on the product ... 5 2.6 Description of warning messages... 5 3 Safety ... 7 3.1 Unsterile product ... 7 3.2 Contaminated products ... 7 3.3 Working with process chemicals ... 7 3.4 Creutzfeldt-Jakob disease ... 7 4 Overview of processes... 8 4.1 Reprocessing cycle for manual wipe disinfection... 8 5 Manual wipe disinfection ... 9 6 Visual inspection ... 10 7 Life span... 11 7.1 Functional check... 11

NOT APPLICABLE FOR THE US Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

3

Target group

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

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

4

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.

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

5

General information

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

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

6

Safety

3 Safety 3.1 Unsterile product The product is not sterile when delivered. The use of unsterile products poses a risk of infection for patients, users, or third parties. Before use, reprocess the product in line with the reprocessing instructions.

3.2 Contaminated products During work on contaminated products, 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.

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

7

Overview of processes

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

Manual wipe disinfection

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

4.1 Reprocessing cycle for manual wipe disinfection

Purchasing

Use

Decontamination

Maintenance, functional test

Repair or disposal

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

8

Manual wipe disinfection

5 Manual wipe disinfection Manual wipe disinfection is not a validated reprocessing procedure. Required materials: –

Disposable cloth and disinfectant Alternatively: ready-to-use disinfectant cloth

–

Dry, low-lint cloth

1.

Prior to wipe disinfection, the product must be separated into its individual components as far as possible.

2.

Use a disposable cloth moistened with disinfectant or a ready-to-use disinfectant cloth to wipe the external surfaces of the product.

3.

Take up any excess moisture with a dry low-lint cloth.

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

9

Visual inspection

6 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.

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

10

Life span

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

7.1 Functional check If the product does not fulfill one of the points listed below or if damage can be identified, see chapter “Maintenance, repair, 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.

4.

Check the correct positioning of the assembled components and, if necessary, also check the cleaning connector.

5.

Check the mobility of all mobile components, if necessary once the components have been assembled in the case of products that can be dismantled.

6.

Check whether the end positions of the application part are reached.

7.

Check the fastening element for damage.

8.

Check whether the fastening element is suitable for the anticipated load to which it will be exposed by the intended application.

Reprocessing instructions • BARANY Noise App. w. olive • 130000_EN_V1.1_02-2021_RI_CE

11