IMAGE1 S CONNECT II TC201 Reprocessing Instructions V1.1 Feb 2021

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 Alcohol-based disinfectants ... 7 3.4 Working with process chemicals ... 7 3.5 Creutzfeldt-Jakob disease ... 7 4 Overview of processes... 8 4.1 Reprocessing cycle for manual wipe disinfection... 8 5 Manual wipe disinfection ... 9 5.1 Additional information on reprocessing ... 9 6 Visual inspection ... 10 7 Life span... 11 7.1 Functional check... 11

NOT APPLICABLE FOR THE US Reprocessing instructions • IMAGE1 S CONNECT II • TC201_EN_V1.1_02-2021_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 ATTENTION 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 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 Alcohol-based disinfectants Alcohol-based disinfectants have a protein-fixing effect and attack materials. Do not use alcohol-based disinfectants.

3.4 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.

3.5 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: –

Manual wipe disinfection

4.1 Reprocessing cycle for manual wipe disinfection

Purchasing

Use

Decontamination

Maintenance, functional test

Repair or disposal

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Manual wipe disinfection

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

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

–

Dry, low-lint cloth NOTICE Damage due to ingress of liquid! Liquid ingress into the product can cause a short-circuit which would damage the product. Do not store any liquids on, above, or close to the product. Do not spray the product directly during disinfection. In the event of ingress of liquid into the product, switch off the product, disconnect it from the power supply, and allow it to dry completely. NOTICE Damage due to contact with disinfectant! Disinfectant impairs the conductivity of electrical connections. Disinfectant must not be allowed to get into electrical connections.

1.

Switch off the device before wipe disinfecting and disconnect from the mains.

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.

5.1 Additional information on reprocessing Additional general information on reprocessing can be requested from [email protected].

Reprocessing instructions • IMAGE1 S CONNECT II • TC201_EN_V1.1_02-2021_RI_CE

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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.

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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.

During commissioning, the equipment performs a self-test, which checks whether the functionality of the medical device has been fully met. If this self-test indicates an error, proceed as described in chapter Maintenance.

5.

Check and inspect the product annually.

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