Instructions for disinfection and sterilization

Remove coarse soiling, if possible immediately after using the device.

The front parts of the devices that come into contact with the skin (A) are unscrewed and separated from the remaining parts (B) of the device.

1. Pre-clean the parts (A) with a soft plastic brush. Then rinse thoroughly with running water (drinking water quality). It is important to ensure that grooves, openings, channels and cavities are also cleaned.

2.1.1 Place the parts (A) on a suitable instrument tray and position them in the cleaning and disinfection device (CDD). Make sure that the spray jet hits the parts (A) directly. The RDG must comply with the ISO 15883 standard.

2.1.2 Put the cleaning agent in the CDD according to the manufacturer's instructions.

2.1.3 Select the standard program (Vario-TD) including thermal disinfection. Thermal disinfection is carried out taking into account an A0 value of 3000 according to ISO 15883 or official specifications and the Robert Koch Institute (RKI) recommendation. Device manufacturer information on cleaning agents must be observed. The cleaning agents and disinfectants must be listed by the RKI.

2.1.4. After the program has finished, remove the parts (A) from the CDD.

2.1.5. End of cleaning

Alternatively, if no washer-disinfector is available according to III 1.:

2.2.1. Manual cleaning is permitted if no washer-disinfector is available. An alkaline cleaning agent should be used.

2.2.2 After cleaning, rinse thoroughly with water so that there are no residues of the cleaning agent.

2.2.3 End of cleaning

Ultrasonic cleaning is not permitted!

1. The handles of the devices and parts (B) are disinfected with a wipe disinfectant. Use Cleanisept Wipes by Dr. Schumacher GmbH. All exterior surfaces must be wiped down.

2.1. The parts (A) are disinfected as immersion bath disinfection. A suitable disinfection tub with sieve insert and lid is used.

2.2 The instrument disinfectant Descoton Forte from Dr. Schumacher GmbH diluted 2% with a working time of 60 minutes at room temperature. Observe the application and safety instructions of the disinfectant manufacturer.

2.3 Move the parts (A) to be disinfected after insertion. It must be ensured that all surfaces of the parts are covered with disinfectant.

2.4 After the exposure time has ended, remove the parts (A) with the sieve insert from the disinfection tub, rinse thoroughly and clean with a soft brush. When applying RDG and performing steps III. 2.1.1 to III. 2.1.4 is omitted IV. 2.1 to IV. 2.4

When using CDD with a drying function according to III.1.3, start the "Drying" program and remove the parts (A) after the end of the program. If there is no CDD with drying function, dry parts (preferably with compressed air according to RKI recommendations).

1. All parts are visually inspected for cleanliness and integrity. Damaged parts must be replaced. A magnifier is to be used as an aid. If residual contamination is observed after machine reprocessing, steps II onwards must be repeated until no such contamination can be found.

2. Parts (A) and (B) are assembled.

3. A functional test is then carried out.

For parts that have to be sterilized, transparent protective packaging suitable for sterilization (sterilization film) in accordance with DIN CEN ISO/TS 16775:2022 and ISO 11607-1 must be used. It must be large enough so that the fastener is not under tension.

1. The parts (A) must be sterilized with a steam sterilizer according to ISO 17665, using the standard procedure with fractionated pre-vacuum (3-fold), sterilization temperature min. 134°C, max. 137°C, 5 minutes sterilization time and then 10 minutes drying time. 2. The sterilant must have access to all internal and external surfaces. To do this, the parts must be placed in such a way that they do not touch one another and the flow can flow around them unhindered. If steps III 2.1.1 to II 2.1.5 were carried out with CDD, this step is omitted.

1. The reprocessed devices are stored in the sterile packaging or in suitable closed containers made of metal or plastic at room temperature.

no special requirements