General Information; Preparation For Cleaning - Novatech TONN Mode D'emploi

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15 Reprocessing
The instructions listed below have been validated by the medical device manufacturer as being capable of preparing a medical
device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using
equipment, materials and personnel in the processing facility achieve the desired result. This requires validation and routine
monitoring of the process. Likewise any deviation by the processor from the instructions should be properly evaluated for
effectiveness and potential adverse consequences.
15.1 Warnings

15.1.1 General information

WARNING
• After use in patients with suspected or diagnosed Creutzfeldt-Jakob disease: Do not process the product again, but dispose of it
correctly.
Otherwise there are risks for the health of your patient.
15.1.2 Cleaning and Disinfection Agents
Do not use cleaning and disinfection agents that contain the following substances:
• Caustic soda
Do not use any rinse agents.
For rinsing only use water with the following properties:
• Low in endotoxins (max. 0.25 endotoxin units/ml; e.g., purified water).
• Sterile / low in germs (max. 10 germs/ml).
Only use agents suitable for cleaning / desinfection of plastic and metals.
15.2 Limitations on Reprocessing
Frequent reprocessing has little impact on these instruments. The end of the product lifetime is usually based on wear and tear as
well as damage from use.
15.3 Pre-treatment at the Point of Use
Clean the product immediately after use from rough impurities, corrosive solutions and drugs. To do this, rinse the product in
flowing cold water and wipe it clean.
15.4

Preparation for Cleaning

Start:
Preparation:
Cleaning solution:
Soaking in cleaning solution:
Rinse:
Ultrasonic bath:
18
As soon as possible, but at the latest 16 h after product use
Open the product as widely as possible / disassemble its individual parts.
Cideyzyme (Johnson & Johnson), 0,5%, 20 °C
Duration of soaking: 5 min
To start the soaking time rinse all lumina at least twice using a single-use syringe
(min 5 ml) with cleaning solution. Brush all surfaces using a suitable brush.
Brush all lumina using a bottle brush in flowing water.
Rinse the following components additionally in cleaning solution in an ultrasonic
bath (10 min, 20 °C):
Basic block, folding device
Then thoroughly rinse the components in cold flowing water (j20 s each).