10318LT, Fiber Optical Light Carrier f.10318CT Processing Instructions

Processing Instruction 10318LT, Fiber Opt.Light Carrier f.10318CT

Table of contents 1

RI/10318LT/E Version: 2.0019

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 Auxiliary pretreatment with ultrasound ... 5 5 Manual cleaning ... 5 6 Manual disinfection ... 5 7 Machine cleaning and disinfection ... 6 7.1 Automated cleaning/thermal disinfection ... 6 7.2 Slide-in tray and instrument holder... 6 8 Assembly, inspection and care... 6 9 Packaging Systems ... 6 10 Sterilization... 7 10.1 Validated sterilization ... 7 Steam sterilization using the fractionated prevacuum procedure ... 7 Hydrogen peroxide (H₂O₂) sterilization – ASP STERRAD®... 7 Hydrogen peroxide (H₂O₂) sterilization – STERIS® AMSCO®... 8 Chemical low-temperature sterilization with STERIS® System 1®... 8 Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E® ... 9 10.2 Optional sterilization ... 9 Low-temperature steam and formaldehyde process (LTSF) ... 9 11 Limits of reprocessing... 9 12 Contact data ... 10

NOT APPLICABLE FOR THE US Page 2 of 11

Processing Instruction 10318LT, Fiber Opt.Light Carrier f.10318CT

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 10318LT, Fiber Opt.Light Carrier f.10318CT

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 10318LT, Fiber Opt.Light Carrier f.10318CT

2 Accessories Accessories required for carrying out reprocessing: Brushes: 27652

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 Depending on the degree of contamination and the degree to which residues have dried, heavy soiling must be cleaned from the surfaces of instruments with the aid of a brush / sponge under cold running water until the visible contamination has been completely removed.

4.3 Auxiliary pretreatment with ultrasound For technical reasons, the medical device is not suitable for ultrasound treatment.

5 Manual cleaning The medical device must be completely immersed in a cleaning solution. To ensure bubble-free wetting, the lumina in particular must be filled. After the necessary exposure time, clean the instrument mechanically with the aid of brushes or a sponge. Finally, it must be rinsed with cold water to ensure neutralization.

6 Manual disinfection The medical device must be completely immersed in a disinfectant solution. To ensure bubble-free wetting, the lumina in particular must be filled. At the end of the required exposure time, the medical device must be rinsed several times in order to remove all chemical residues. For this purpose, water of the best possible quality, but at least of potable water quality, must be used.

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Processing Instruction 10318LT, Fiber Opt.Light Carrier f.10318CT Finally, all of the surfaces, joints, openings, channels and lumina are dried completely with (preferably sterile) compressed air in accordance with the national regulations. The cleaning gun with accessories (Art. no. 27660) is ideal for this purpose.

7 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):

7.1 Automated cleaning/thermal disinfection Thermal disinfection is preferred. The relevant national requirements and the A0 value must be taken into account when using this method.

7.2 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.

8 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. – Dismantled medical devices must be assembled. – Afterwards, a functional check must be carried out.

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

9 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 10318LT, Fiber Opt.Light Carrier f.10318CT

10 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.

10.1 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.

- Hydrogen peroxide (H₂O₂) sterilization – ASP STERRAD® NOTICE Lubricated and oiled surfaces cannot be sterilized.

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Processing Instruction 10318LT, Fiber Opt.Light Carrier f.10318CT

WARNING Sterilize medical devices in the disassembled state.

NOTICE The "Sterrad® Sterility Guide" can be used to verify whether the relevant medical device can be sterilized using the different Sterrad® devices. The following Sterrad® sterilization methods have been validated and approved for this medical device by KARL STORZ:

Sterrad® 50, 100S, 200

STERRAD® NX™ Advanced Cycle

STERRAD® NX™ Standard Cycle

STERRAD® 100NX® Standard Cycle

- Hydrogen peroxide (H₂O₂) sterilization – STERIS® AMSCO® Detailed information on selecting the appropriate cycle in the various device generations is available from the manufacturer of Steris®.

NOTICE Lubricated and oiled surfaces cannot be sterilized.

- Chemical low-temperature sterilization with STERIS® System 1® For detailed information on selecting the sterilization parameters and on the Steris® Quick Connect Kit (QCK) required to flush lumina, please contact the manufacturer of Steris®.

NOTICE Lubricated and oiled surfaces cannot be sterilized.

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Processing Instruction 10318LT, Fiber Opt.Light Carrier f.10318CT

- Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E® Detailed information on the selection of the sterilization parameters and the STERIS® Quick Connect Kit (QCK) required to rinse out the lumens is available from the manufacturer STERIS®.

NOTICE Lubricated and oiled surfaces cannot be sterilized.

10.2 Optional sterilization The following procedures are approved in respect of material compatibility, but must be validated by the local operating company with regard to efficacy:

- Low-temperature steam and formaldehyde process (LTSF) NOTICE If FO sterilization is to be performed, the method must be validated on site.

NOTICE Lubricated and oiled surfaces cannot be sterilized.

11 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 10318LT, Fiber Opt.Light Carrier f.10318CT

12 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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