HF-GB-17664, Rev. D | Page 3 / 8 Status: 07/2023

CLEANING PROCEDURE: Place the devices in an ultrasonic bath containing a cleaning solution at min. 45°C for at least 15 minutes*. At the beginning of the soak time flush the lumens with 5 ml of the cleaning solution using a syringe. Non-rigid components shall be operated during the immersion. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed at least 3 times with minimum 50 ml cold deionized water, using a syringe or a rinsing adapter.* Remove the instruments from the cleaning solution. Rinse the instruments under running water for at least 1 minute. Inspect optically for proper cleaning.

* These parameters are validated for Enzymax Liquid. For other cleaning agents and disinfectants, the instructions of the manufacturer must be observed.

DISINFECTION PROCEDURE: Soak the devices in the disinfectant solution for the duration intended by the disinfectant manufacturer. Make sure they are completely immersed. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed with the disinfectant, using a syringe or a rinsing adapter. Non-rigid components shall be operated during the immersion Remove the instruments from the disinfectant. Rinse the instruments under deionized water for at least 1 minute*. Let the instruments dry. Conduct post- disinfection steps (see sections 4.0)

* These parameters are validated (Validation Report: 10918-1)

The fundamental suitability of the instruments for an effective automatic cleaning and disinfection was demonstrated by an independent accredited test laboratory under the following conditions:

Cleaning Solution

0.8 % Enzymax Liquid (Hu-Friedy Mfg. Co., LLC, USA)

Validation Report

Project Number: 00418-2 Examination of a Manual Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method

The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.

4.0 Post- Disinfection Steps

4.1 Inspection and Maintenance If there are still contamination attached to the instruments, clean and disinfect again.

Inspect all instruments after the cleaning and disinfection step for corrosion and damaged surfaces, Light corrosion on the surface can be removed with Shine reNew (IMS-1455). If the corrosion cannot be completely eliminated, the instruments should be removed from use. Otherwise such corrosion could damage other instruments. After treating an instrument with Shine reNew, the instrument must be cleaned and sterilized once more. Keep in mind that instruments shall no longer be reused in case the labelling is fading.

Re-sharpen instruments if necessary. Afterwards, completely remove any residues, such as metal residue or sharpening oil. Assemble disassembled instruments if necessary (see 9.0 Special Procedures section).

Hinged instruments have to be lubricated with a lubricant suitable for steam sterilization, like Hu-Friedy Instrument Lubricant Spray (ILS).

4.2 Packaging All instruments must be completely dry before packaging. Then, package immediately.

We recommend the use of a cassette system, like the Hu-Friedy IMS System and Hu-Friedy Bagettes (pouches), Hu-Friedy Sterilization wrap (Hu-Friedy IMS-1210M, IMS-1211M, IMS-1212M), Hu-Friedy Bonded Double Wraps (IMS-2215, IMS-2220, or IMS-2224) or suitable sterilization containers, if the following requirements are fulfilled: - Conformity with EN ISO/ANSI AAMI ISO 11607-1 and 2 and applicable parts of EN 868 - suitable for steam sterilization (temperature resistance up to at least 141 °C (286 °F), sufficient steam permeability) - sufficient protection of the instruments and the sterilization packaging against mechanical damage - regular maintenance according to the manufacturer’s instructions (Sterilization Containers: limitations also see 9.0 Special Procedures section)

5.0 Sterilization Please use only the recommended sterilization procedures listed below. Other sterilization procedures are the responsibility of the user.

Restrictions: The flash sterilization procedure must not be used! Do not use radiation sterilization, formaldehyde sterilization, ethylene oxide sterilization, or plasma sterilization!

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