5 Reprocessing
11
EN
Take the following steps:
1. If necessary, soak a cotton cloth in the disinfectant solution.
2. Wipe the surfaces of the suction cannulas, cannula adapters and headphones thoroughly with the soaked cotton cloth
or disinfectant wipes.
3. Alternatively, place the suction cannulas and cannula adapters in a disinfection bath/disinfectant solution.
4. Leave the disinfectant to take effect in accordance with the instructions for use.
5. Then perform thermal disinfection (see Chapter 5.4) or sterilization (see Chapter 5.5).
Follow the instructions provided on the disinfectant to ensure you use it properly.
5.4
Thermal disinfection
Mechanical internal and external cleaning and disinfection in a washer disinfector in accordance with ISO 15883.
Damage to the product
Only the suction cannulas and cannula adapters may be thermally disinfected.
The
headphones
cannot
be thermally disinfected.
Product is damp following reprocessing
Failure to properly take care of the product may lead to malfunctions or breakdowns.
Follow suitable cleaning and drying procedures.
Make sure that the medical device is dry following reprocessing.
In some countries, national guidelines require mechanical reprocessing to be conducted using a validated washer
disinfector (WD), such as SciCan HYDRIM M2 or C61.
Follow the instructions for use.
Validated parameters for cleaning and disinfection processes
Cleaning agent:
TPH 5949 (S&M)
pH value:
Max. 10
Program:
Thermal disinfection
Temperature:
≥ 93°C (199°F)
Exposure time:
≥ 5 minutes
Drying time:
≥ 15 minutes
Only use WDs with an integrated drying function.
On the WD, choose a suitable program with drying.
Observe the applicable national guidelines.
How to choose an appropriate washer disinfector (WD)
When performing mechanical cleaning and disinfection, it is essential to choose a WD with the following properties and
validated processes:
•
Compliance with EN ISO 15883 with tested efficiency
•
Tested program for thermal disinfection (A0 value ≥ 3,000 or min. 5 minutes at 93°C)
•
Suitable program for the components with a sufficient number of flushing cycles
How to choose appropriate cleaning agents and disinfectants
The following properties are essential for mechanical processing:
•
Suitable for use with the product
•
Meets the requirements of the WD’s manufacturer