INSTRUMENTS

Reusable instruments:

Sharp instruments; suture instruments; general surgery instruments; Orthopaedic and traumatological surgery instruments; Microsurgical instruments; ENT instruments; Odontostomatology instruments; Ophthalmic instruments; Diagnostic instruments; Devices for sterilization and packaging.

WARNINGS

The instruments may only be used for their intended purpose and only by trained and qualified personnel. . Under no circumstances should you use instruments that have been damaged, for instance during transport, storage or use. The instruments must not show signs of wear and must be properly assembled so that they properly fulfill their purpose and are fully clinically useful.

The instruments must be treated with due care in accordance with the recommendations provided by their manufacturer in this instruction. Please remember that only clean, disinfected and dry instruments can be effectively sterilized.

LIMITATIONS IN RE- PROCESSING

Each time before using the instrument, check its quality and technical condition, the degree of wear of the elements and possible damage. The instrument should be functional, free from biological contamination and residues from the washing, disinfection and sterilization process, as well as without damage to the structure of the material. Detailed guidelines for checking the technical condition of instruments can be found in the "Warnings and contraindications" section.

INSTRUCTIONS

POINT OF USE

The instruments are delivered to the user in a non-sterile condition. They are reusable instruments intended for performing procedures in clinical conditions. The instruments should be cleaned both before first use and immediately after use.

They should not be allowed to get heavily dirty, and intense dirt must be removed immediately.

STORAGE AND TRANSPORT

It is recommended that contaminated instruments be transported in tightly closed containers.

When transporting instruments, they must be protected against damage and moisture and must be traceable.

Pre-treatment should take place immediately after use.

INITIAL DISINFECTION AND PREPARATION FOR CLEANING

After use, the instruments should be immediately soaked in an aqueous solution of a preparation intended for disinfection and cleaning of reusable medical instruments (e.g. DürrDental ID212 Forte). The concentration of the solution and the soaking time should comply with the indications contained in the manufacturer's instructions, but the soaking time should not exceed 1 hour to prevent damage to the surface of the instruments. Organic residues should not be allowed to dry, especially large contaminations must be removed immediately after use. After the procedure, the cannulated instruments should be cleaned with a guide wire to remove contamination from the cannula. If the accumulated contamination cannot be removed from the cannula, it should be considered that the product has expired and should be disposed of.

INITIAL CLEANING AND RINSING

The instruments should be pre-treated immediately after removal from soaking. Storing used instruments with blood or other contamination may cause corrosion damage to the instruments and prevent their subsequent effective cleaning/sterilization, thus leading to cross-infections.

Equipment used: nylon brush, running water at a temperature of 20 ± 2°C and at least drinking water quality.

1. Rinse tools under running water for 60 seconds and brush thoroughly with a nylon brush, focusing on hard-toreach places. Particular attention should be paid when cleaning: slots, teeth, connectors, threads, cannulas, holes or other hard-to-reach areas. It is advisable to use brushes with nylon bristles, including appropriate brushes for cleaning cannulated elements - do not use wire brushes.
2. Rinse the instruments under warm running water, making sure to rinse all crevices and holes thoroughly.
3. Visual inspection of instruments – the preliminary cleaning should remove all biological contamination, there should be no stains or streaks on the instruments. If contamination is still present, repeat the cleaning process.

Depending on the available equipment, perform basic cleaning and disinfection using manual or automatic methods as described below.

MANUAL CLEANING, BASIC DISINFECTION AND DRYING

Equipment used:

- disinfection bathtub,

- ultrasonic washer,

- an agent intended for disinfection and cleaning of reusable medical instruments (e.g. DürrDental ID212 Forte) or another agent approved for disinfection and cleaning of reusable medical instruments,

- hot water with a temperature not exceeding 42°C, treated and demineralized.

Proceeding:

1. Prepare the solution according to the manufacturer's instructions (e.g. DürrDental ID212 Forte, 2% solution) and fill the disinfection bath or ultrasonic washer.
2. Completely immerse the instruments in the solution.
3. If you use a disinfection bath, clean the instruments with a nylon brush. Leave the instruments in the bath for a period of time in accordance with the recommendations of the manufacturer of the cleaning agent and the manufacturer of the washer, but not less than 5 minutes in the bathtub or not less than 1 minute in the washer.
4. Remove tools from the solution and rinse thoroughly with demineralized water for 30 seconds.
5. Check cleanliness. If any dirt remains, repeat the above steps. If the tools are clean, dry them, e.g. wipe them with a disposable, lint-free, clean cloth and leave them to evaporate water from hard-to-reach places before packaging.

NOTE: The instructions of the manufacturer of the cleaning and disinfection agent in terms of dosage, concentration, temperature, material compatibility and time of use, as well as the relevant instructions of the washer manufacturer, must be followed. Change the fluid according to the manufacturer's instructions.

NOTE: Instruments that consist of several elements that are not integrally connected with each other should be disassembled as much as possible for washing, basic disinfection and drying. This applies to the following tools:

- Crown removers

- Ori-ject syringes

AUTOMATIC CLEANING AND DISINFECTION

Equipment and preparations used:

- washer-disinfector validated in accordance with the EN ISO 15883 series standards

- preparations intended for washing and disinfecting reusable medical instruments in washer-disinfectors, preferably containing additional corrosion inhibiting agents

The instructions for use of cleaning and disinfecting preparations indicated by their producers must be followed.

- demineralized water.

Proceeding

Place the instruments on an appropriate tray or load carrier so that all instrument surfaces are cleaned and disinfected. It is advisable to wash instruments with a long cannula, e.g. applicators, on a trolley that allows pressurized water to be pumped into the cannula. Small pieces of instrumentation should be placed in baskets with a lid.

1. Close the washer-disinfector and run the program recommended by the manufacturer of the device used and the manufacturer of the cleaning and disinfection preparation.
2. Remove instruments at the end of the program.
3. Visually check the cleanliness of the tools after removing them from the equipment. If any contamination remains, the instruments should be cleaned again by hand. Tools cleaned in this way should be subjected to automatic cleaning and disinfection again.

The stages of the automatic cleaning, disinfection and drying process in the washer-disinfector must comply with the EN ISO 15883 series standards.

NOTE: Instruments that consist of several elements that are not integrally connected with each other should be disassembled as much as possible for washing, basic disinfection and drying. This applies to the following tools:

- Crown removers

- Ori-ject syringes

INSPECTION AND FUNCTIONALITY CHECK

After cleaning, disinfection and drying, all instruments should be visually inspected for cleanliness, integrity and function, using a lighted magnifying glass if necessary. If any dirt is found, repeat the cleaning and disinfection process. In addition, all tools should be visually inspected for damage and wear. Cutting edges are required to be undamaged and have continuous, sharp edges. Check correct assembly and whether the products retain their usability functions and if damage is found, the tool cannot be reused and must be separated.

MAINTENANCE

After washing and disinfection, and before sterilization in an autoclave, lubricate all moving parts of the instrument. Use an instrument maintenance agent suitable before steam sterilization (e.g. STERILIT® I oil) and cover the entire joint surface so that the oil does not flow beyond the moving parts of the instrument. Excess oil should be collected with a sterile gauze pad. Preservatives that are suitable for steam sterilization and are permeable to steam should be used.

PACKAGING

Materials and equipment used:

- foil and paper packaging intended for steam sterilization in accordance with the EN ISO 11607 series standards,

- equipment for sealing foil and paper packaging.

acking should be carried out in a room with controlled microbiological cleanliness. Make sure the package is large enough so that the packed instrument does not cause any tension in the welds. Instruments with sharp edges/tips should be packed in such a way as to prevent damage to the packaging. Place an appropriate indicator (test) of the effectiveness of the sterilization process in the packaging. Instruments should be sterilized on the pallet on which they were delivered, placed in a sterilization container.

NOTE: After welding, the sealing joint should be visually inspected for defects. If a defect is found, the packaging should be opened and the instruments repacked and sealed.

STERILIZATION

Equipment used

Steam sterilizer compliant with EN 285:2015+A1:2021 or compact steam sterilizer compliant with EN 13060:2014+A1:2018, process type B - validated in accordance with applicable standards (EN ISO 17665-1:2006, EN ISO 14937:2009) and established procedures.

Sterilization method

Steam sterilization at a temperature of 134°C for a minimum of 5 minutes and a minimum drying time of 20 minutes is recommended. When sterilizing multiple instruments in one cycle, make sure that the maximum sterilizer load is not exceeded. In order to avoid damage to the instruments during sterilization, the individual elements must be separated from each other.

Proceeding

1. Place the packaged products in the sterilization chamber.
2. Run the program.
3. At the end of the program, remove the products and allow it to cool down.
4. Inspect packaging for damage or effects of overexposure. Damaged packaging is considered unsterile. The instruments should be subjected to cleaning, disinfection and sterilization processes again.

NOTE: Crown removers must be assembled before the sterilization process, while the components of the Ori-ject syringe must be sterilized disassembled in one package and only the user should assemble them just before use, taking all precautions not to contaminate them during assembly.

RESTERILIZATION

Instruments can be re-washed, disinfected and sterilized 200 to 500 times depending on the type of instrument. The manufacturer assumes this amount to be safe for the products, but the suitability of the instruments for use depends on their degree of wear - see the "Warnings and contraindications" section below. The user is responsible for the amount of instrument sterilization.

STORAGE

Sterilized products should be stored in a way that ensures protection against packaging damage and recontamination, in accordance with own procedures and applicable national requirements.

TRANSPORTATION

Instruments should be transported to the place of use in tightly closed containers protecting against damage, moisture and loss of sterility. The traceability of instruments must be ensured.

WARNINGS AND CONTRAINDICATIONS

Although materials were used in the manufacturing process to ensure increased corrosion resistance, the number of cycles depends on many factors, including the correct performance of cleaning, disinfection, drying and sterilization processes, maintenance and proper use of instruments. The instruments do not have an expiration date. Their shelf life depends on the wear and tear resulting from their use. The instrument should be checked before each use to confirm its proper operation. Check all moving parts (e.g. hinges, locks, joints, etc.) for full mobility. Visible damage, cracks, surface defects, deformed components or blunt blades mean that the instrument should be removed from use immediately.

ADDITIONAL INFORMATION

The instructions provided above have been validated and are suitable for reprocessing medical instruments. Please remember that handling tools according to their intended use and processing in accordance with these instructions extends their shelf life. In case of any questions or ambiguities, please contact the company's headquarters directly as follows.