Instructions for Cleaning, Disinfection and Sterilization

IMPORTANT! READ CAREFULLY BEFORE USE; KEEP SAFE TO REFER TO AT A LATER POINT With regard to water quality, MONDEAL recommends using demineralized and purified water (e.g. aqua purificata) for the cleaning, disinfection and rinsing steps.

Instructions for Cleaning, disinfection and sterilization

Pre-treatment for cleaning, disinfection and sterilization • Coarse impurities should be removed from the products immediately after use (within a maximum of 2 hours). • In order to enable efficient cleaning and disinfection, products that consist of several parts and which can be dismantled are to be dismantled according to the product-specific instructions for use, if applicable, and the instructions in the section "Special instructions". • Use clean water or a suitable disinfectant solution for cleaning the products and individual parts (see chapter "Selecting cleaning agents, disinfectants and devices"). • To remove impurities manually, use a soft brush or a clean, lint-free cloth, but never metal brushes or steel wool. • Move movable parts back and forth, clean cannulated products using cleaning wire, and syringes and cannulas and larger lumens with a bottle brush, if necessary. • The products should be inspected visually and, if necessary, pre-treatment should be repeated until no visible contaminants are left.

Notes on cleaning, disinfection and sterilization Basic Instructions for cleaning, disinfection and sterilization of implants and instruments from MONDEAL Medical Systems GmbH (hereinafter referred to as MONDEAL). All implants, instruments and containers of MONDEAL systems that are delivered NON-STERILE must be cleaned, disinfected and sterilized before each use; this also applies to the first use after delivery (after removal of the protective packaging for transport). Effective cleaning and disinfection is an essential requirement for effective sterilization. Contaminated Implants must be disposed of in line with local requirements. They must not be reprocessed. Re-using single-use products can impair the structural integrity of the implants and increases the risk of functional failure, which can lead to injuries to and/or illness in the patient. Re-using single-use products also creates a contamination risk, e.g., due to transmission of germs from patient to patient. This can result in injury to and/or illness in the patient and/or user. Unused but contaminated implants should be cleaned and disinfected separately before being placed back in the implant tray. We recommend that you no longer use heavily contaminated instruments and those that are hard to clean (e.g., with small dimensions, cannulated screws or encrustations in places that are difficult to clean) and dispose of them immediately if safe processing cannot be guaranteed.

Please bear in mind that the disinfectant used during the pre-treatment is only for personal protection and is no substitute for the disinfection stage conducted at a later point, after cleaning has taken place.

Machine cleaning/disinfection When selecting the cleaning agents and disinfectants, the chapter "Selecting cleaning agents, disinfectants and devices" must be observed. Likewise, the concentrations specified by the manufacturer of the cleaning agent and, if applicable, disinfectant must be adhered to, without fail. When selecting the disinfector, it must be ensured that the following phases are part of a cleaning process, in accordance with EN ISO 15883:

As part of your responsibility for the sterility of the implants, please ensure during application that, in principle, only sufficiently validated device-specific and product-specific methods for cleaning/disinfection and sterilization are used, that the equipment used (cleaning and disinfection unit, sterilizer) is regularly maintained and tested, and that the validated parameters are adhered to during every cycle. Please also observe the applicable legal provisions in your country as well as the hygiene regulations of the doctor's practice or hospital. This applies in particular to the different specifications with regard to effective deactivation of prions.

Phase

Temperature

Duration

Action

Rinsing

cold

1 min.

rinse with cold water

Cleaning

55°C

10 min.

add the cleaning agent

Neutralization

cold

2 min.

neutralize with cold water

Thermal disinfection

≥ 93°C

5 min.

with demineralized and purified water; do not add any additional cleaning agent

Drying

≥ 100°C

20 min.

drying process

Basic principles When inserting the implants and instruments into the cleaning and disinfection unit, make sure that the products do not touch each other and that they are aligned in such a way that no large liquid residues are able to remain on or in the product. It is important to ensure that the products are well rinsed and that there is no foam residue.

If possible, a machine method should be used for cleaning and disinfection of the instruments (cleaning and disinfection unit/disinfector). Manual methods – even using an ultrasonic bath – should only be used when a machine method is unavailable, as these are significantly less effective and reproducible.1 Pre-treatment must be carried out in both cases. 1

The use of a manual cleaning and disinfection method must be backed up by an additional product- and method-specific validation, which is the responsibility of the user.

Proof of the products' basic suitability for effective machine cleaning and disinfection was provided by an independent accredited testing laboratory using the "Miele PG 8535" cleaning and disinfection unit (thermal disinfection, Miele & Cie. GmbH & Co., Gütersloh) and the cleaning agent "Neodisher mediclean forte" (Dr. Weigert GmbH & Co. KG, Hamburg). In doing so, the method described above was observed.

Selection of cleaning agents, disinfectants and devices When selecting the cleaning agents, disinfectants and devices used, it must be ensured at all stages that: • These are suitable for the intended use (e.g., cleaning, disinfection, ultrasonic cleaning) • The cleaning agents and disinfectants are non-protein-fixing (aldehyde-free) • These are proven to be effective (e.g., VAH/DGHM or FDA approval or CE marking) • The cleaning agents and disinfectants are suitable for the products and are compatible with the products • The manufacturer's instructions, e.g., with regard to concentration, exposure time and temperature, are adhered to

Inspection (implants and instruments) Check all implants for damage and contamination after cleaning and disinfecting and prior to sorting into the implant containers and discard damaged and soiled implants. Check all instruments after cleaning and disinfection for damage (e.g. corrosion, damaged surfaces, chips, etc.), contaminants and functionality. Damaged instruments must be discarded. In addition, instruments with lumens (e.g. cannulated drills) must be checked for patency, cutting instruments for sharpness, and rotating instruments for deflections. Instruments that are still dirty must be cleaned again.

When using cleaning aids, as well as during pre-cleaning, it must be ensured that: • Only clean, lint-free cloths and/or soft brushes are used (never metal brushes or steel wool) • If necessary, aids are used, such as cleaning pens, syringes, cannulas, bottle brushes for cannulated products or products with lumens. For drying the products, MONDEAL recommends lint-free disposable cloths or medical compressed air.

Instructions for Cleaning, Disinfection and Sterilization MONDEAL Medical Systems GmbH

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97-IFU-002-E Rev.06 21.01.2021