26159SHW, Scissors, pointed, 5 Fr., 34 cm Processing Instructions

Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

Table of contents 1

RI/26159SHW/E Version: 2.0010

1 Safety section ... 3 2 Accessories... 5 3 Preparation for cleaning and disinfection ... 5 4 Manual precleaning... 5 4.1 Disassembly... 5 4.2 Brushing the surfaces ... 5 4.3 Rinsing out with a pressure water gun ... 5 4.4 Auxiliary pretreatment with ultrasound ... 5 5 Machine cleaning and disinfection ... 5 5.1 Automated cleaning/thermal disinfection ... 5 5.2 Slide-in tray and instrument holder... 6 6 Connecting... 6 7 Assembly, inspection and care... 6 8 Packaging Systems ... 6 9 Sterilization... 7 9.1 Validated sterilization ... 7 Steam sterilization using the fractionated prevacuum procedure ... 7 10 Limits of reprocessing... 7 11 Contact data ... 8

NOT APPLICABLE FOR THE US Page 2 of 9

Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

1 Safety section Description of warnings and cautions NOTICE Notes contain special information regarding reprocessing or important explanations.

CAUTION A caution indicates that particular procedures or precautions must be followed to avoid possible damage to the medical devices.

WARNING A warning indicates a potential hazard. Failure to observe a Warning may result in injury to the patient, user or third parties.

General warnings NOTICE The instructions "Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments" can be downloaded or ordered at www.karlstorz.com.

CAUTION Compliance with manufacturer's specifications When preparing and using solutions, carefully follow the chemical manufacturer's instructions regarding concentration, exposure time, and hold time. Over-long immersion and incorrect concentration can cause damage. Bear in mind the microbiological range of action of the chemicals used!

CAUTION Risk of damages to the medical device The use of chemicals which have not been approved by KARL STORZ may cause damage to the medical devices. ▸ Only use chemicals approved by KARL STORZ for reprocessing. For a complete list, please visit www.karlstorz.com

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Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

WARNING Risk of infection Improperly reprocessed medical devices can pose a risk of infection for patients, users, and third parties and can cause malfunction of the medical device. ▸ Observe the ‘Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments’ instructions and the accompanying documentation!

WARNING Risk of infection This medical device is not sterile when delivered. The use of non-sterile medical devices poses a risk of infection for patients, users, and third parties. ▸ Inspect medical device for visible contamination. Visible contamination is an indication that reprocessing has not been carried out or has been carried out incorrectly. ▸ Reprocess the medical device before initial use and before and after every subsequent application using validated methods!

CAUTION Country-specific laws and regulations must be observed.

WARNING Compliance with directives When carrying out any work on contaminated medical devices, the personal safety guidelines of the Employers' Liability Insurance Association and equivalent organizations must be observed.

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Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

2 Accessories Accessories required for carrying out reprocessing: Brushes: 27652 Adaptor: 39107A

3 Preparation for cleaning and disinfection Gross soiling, corrosive solutions, and pharmaceuticals must be removed from the medical device immediately after use. To do this, pre-clean the medical device by e.g. wiping down and rinsing. As a general rule, KARL STORZ recommends manual precleaning under cold running water.

4 Manual precleaning 4.1 Disassembly Prior to cleaning and disinfection, the medical device must be separated into its individual components as far as possible, and/or must be opened.

4.2 Brushing the surfaces Any visible contamination or heavy soiling must be removed by cleaning the surfaces under cold running water with the aid of a brush or sponge

4.3 Rinsing out with a pressure water gun The working channel, lumina and hollow spaces must be rinsed using a pressure water gun and a suitable rinsing attachment. For rinsing, pulse at least 3 times for 5 seconds from a jet of water with a pressure of at least 2.5 bar. The cleaning gun with accessories (Art. no. 27660) is ideal for this purpose.

4.4 Auxiliary pretreatment with ultrasound To ensure efficient preparation of the medical device, an ultrasound treatment is essential. The exposure time must be at least 10 minutes at a frequency of approx. 35 kHz. The device must then be rinsed with cold water to ensure neutralization.

5 Machine cleaning and disinfection The following methods for machine decontamination have been validated and approved subject to compliance with the process parameters described in the manual, ‘Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments’ (Art. no. 96216003):

5.1 Automated cleaning/thermal disinfection Thermal disinfection is preferred.

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Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm The relevant national requirements and the A0 value must be taken into account when using this method.

5.2 Slide-in tray and instrument holder The selection of a suitable slide-in tray or instrument holder, which should ensure that the medical device is thoroughly rinsed out or through, must take place in consultation with the manufacturer of the device.

NOTICE If necessary, the instrument must be dried off afterwards by hand.

6 Connecting In order to ensure effective machine cleaning, disinfection and rinsing, the instrument must be connected in the washer and disinfector.

7 Assembly, inspection and care The cleaned and disinfected medical device must be visually inspected for cleanliness, completeness, damage and dryness: – If residues or contamination are still present, the medical device must be manually re-cleaned and subjected to another full cleaning and disinfection procedure. – Damaged or corroded medical devices must be withdrawn from use. – Joints, threads and glide surfaces must be treated locally with instrument oil and/or special lubricant – Dismantled medical devices must be assembled. – Afterwards, a functional check must be carried out.

NOTICE The oil used for this purpose must be suitable for the subsequent sterilization method (silicone-free and based on paraffin or white oil).

NOTICE For care, use the items from the "Care, Sterilization, and Storage Techniques" catalog.

8 Packaging Systems Only standardized and approved packaging materials or systems may be used (EN 868 Parts 2-10, ISO 11607 Parts 1 + 2, DIN 58953).

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Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

9 Sterilization The procedures as well as the process-relevant parameters for the individually validated methods are described in detail in the manual ‘Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments’ (Art. no. 96216003). The method must be selected taking into account the respective applicable national requirements and in consultation with the device and product manufacturers.

9.1 Validated sterilization The following sterilization procedures have been validated and approved by KARL STORZ for this medical device:

- Steam sterilization using the fractionated prevacuum procedure NOTICE Sterilize greased components in a disassembled state.

The medical device must be sterilized in its fully assembled state using the fractionated prevacuum procedure (DIN EN ISO 17665-1) with the following parameters: • 132 °C–137 °C for an exposure time of min. 4 to max. 18 minutes (This validation is applicable to reusable tube sets which are open at both ends and have a maximum length of 200 cm). • 134 °C–137 °C for an exposure time of min. 3 to max. 18 minutes.

NOTICE This validation is applicable to reusable tube sets with a maximum length of 200 cm.

10 Limits of reprocessing The end of the product’s service life is largely determined by wear, reprocessing methods, the chemicals used and any damage resulting from use.

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Processing Instruction 26159SHW, Scissors, pointed, 5 Fr., 34 cm

11 Contact data KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen/Germany Postfach 230 78503 Tuttlingen/Germany Germany Tel: +49 (0)7461 708-8126 Fax: +49 (0)7461 708-75047 E-mail: [email protected] Web: www.karlstorz.com

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