Alar Splint for 488065 B Reprocessing Instructions

07-2022 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 Pre-Cleaning ... 11 7.1.2 Automated cleaning / thermal disinfection ... 11 8 Visual inspection ... 12 9 Life span ... 13 9.1 Functional check ... 13 10 Packaging ... 14 11 Sterilization ... 15 11.1 Steam sterilization ... 15

NOT APPLICABLE FOR THE US Reprocessing instructions • Alar Splint for 488065 B • 488065A_EN_V36.1_07-2022_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.

Reprocessing instructions • Alar Splint for 488065 B • 488065A_EN_V36.1_07-2022_RI_CE

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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 Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product. Dispose of the product properly.

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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

Pre-Cleaning Brushing the surfaces

Brush, item no. 27652

Cleaning and disinfection 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.

6.1 Transport to the reprocessing site 1.

Right after using / bedside pre-cleaning of the product, place it in a suitable dry 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: thermal disinfection

7.1 Reprocessing with automated decontamination 7.1.1 Pre-Cleaning 7.1.1.1 Brushing surfaces Requisite materials: –

Brush, item no. 27652

1.

Clean the surfaces of the product under cold running water with a brush.

2.

Brush the surfaces until residue can no longer be seen.

3.

Irrigate the surfaces with cold running water.

7.1.2 Automated cleaning / thermal disinfection A washer-disinfector for thermostable devices must be used for the device. The washerdisinfector must meet the requirements of standard ISO 15883. The A0 value of the disinfection process must be observed. Required materials: –

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

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. Thermal disinfection 5. 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.

4.

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

5.

Check the cutting edge or tip 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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Sterilization

11 Sterilization The sterilization processes described below have been validated and approved for this medical device by KARL STORZ. Select the suitable procedure, taking into consideration the country-specific regulations and in consultation with the device manufacturer.

11.1 Steam sterilization When carrying out sterilization using saturated steam, the steam sterilizer with fractionated vacuum and the sterilization process must meet the requirements of the following standards: –

EN 285 Large steam sterilizers – Requirements and test procedures

–

DIN EN 13060 Small steam sterilizers

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DIN EN ISO 17665 for routine monitoring

Within the scope of validation, the following material was used: –

KLS Martin Group marSafe® container Sterilize the product using a fractionated vacuum procedure (DIN EN ISO 17665) with the following parameters: 134°C–137°C with a minimum contact time of 3 minutes and maximum contact time of 18 minutes

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