Automated Cleaning / Disinfection (With Rdg (Thermal Washer Disinfector)); Manual Cleaning And Disinfection - Coltene CanalPro Jeni Manual De Instrucciones

CanalPro Jeni
1.3.

Automated cleaning / disinfection (with RDG (thermal washer disinfector))

Care must be taken when selecting the (RDG) thermo washer disinfector to ensure
- that the thermo washer disinfector has a tested effectiveness (CE marking) in principle,
- that a tested program for thermal disinfection (A
possible (risk of disinfectant residues on the products/product components in the event of chemical disinfection),
- that the program used is suitable for the products/product components and contains sufficient rinsing cycles,
- that only DI water is used for rinsing (The bacterial load must correspond at least to that of drinking water with a maximum of 100 CFU
and with a low endotoxin load at the same time) (The DI supply of the device must be checked regularly, as bacteria can accumulate
in cartridge systems. Filter systems to reduce the bacterial load are recommended),
- that the air used for drying is filtered (oil-free, low bacterial count and low particle count) and
- that the thermo washer disinfector is regularly maintained and correctly checked.
Care must be taken when selecting the cleaning agent system used to ensure
- that these are suitable for the cleaning of instruments made of metals and plastics in principle,
- that – if no thermal disinfection is used – a suitable disinfectant with tested effectiveness (e.g. VAH/DGHM-listing or CE marking) is
additionally used and that this is compatible with the cleaning agent used and
- that the chemicals used are compatible with the products/product components (see chapter `Material resistance´ in section 1.1.).
The concentrations, temperatures, residence times and rinsing specifications specified by the manufacturer of the cleaning agent and
disinfectant, must be adhered to in any case.
Procedure:
1. Place the dismantled products/product components (see chapter `Pre-treatment´) in the thermo washer disinfector. Make sure that the
products/product components do not touch each other in the process. Use a "small parts basket" for smaller components (see `Special
instructions´).
2. Start the program. e.g. Vario-TD (Miele)
3. Remove the products/product components from the thermo washer disinfector at the end of the program.
4. Inspect and pack the products/product components as soon as possible after removal (see the chapters `Inspection´, `Maintenance´
and `Packaging´, if necessary after additional drying in a clean place).
An independent accredited and recognised (§ 15 (5) MPG) test laboratory (Medical Device Services – DR: ROSSBERGER GmbH, Gilching)
has provided proof of the general suitability of the products/product components for effective automated cleaning and disinfection by using
the RDG G 7836 CD (thermal disinfection, Miele & Cie. GmbH & Co., Gütersloh) and the cleaning agent Neodisher MediClean forte (Dr.
Weigert GmbH & Co. KG, Hamburg). The selected parameters corresponded to the Vario-TD program from Miele. The method described
above was considered and the combined cleaning/disinfection agent ID 213 (DÜRR Dental, Bietigheim-Bissingen) with a concentration of
2% was used for preliminary cleaning.
1.4.

Manual cleaning and disinfection

Care must be taken when selecting the combined cleaning- and disinfection-agent to ensure
- that these are suitable for the cleaning and disinfection of instruments made of metals and plastics in principle,
- that these are suitable for ultrasonic cleaning (no foam development),
- that these have a tested effectiveness (e.g. VAH/DGHM listing or CE marking) and
- that these are compatible with the products/product components (see chapter `Material resistance´ in section 1.1).
The concentrations, temperatures, residence times and rinsing specifications specified by the manufacturer of the cleaning/ disinfection-
agent must be adhered to in any case. Use only freshly prepared solutions, only DI water (The bacterial load must correspond at least to
that of drinking water with a maximum of 100 CFU. The endotoxin load should be low). Only use a soft, clean and lint-free cloth and/or
filtered air for drying.
Procedure
Cleaning:
1. Place the dismantled products/product components (see chapter `Pre-treatment´) in the ultrasonic bath filled with the cleaning/
disinfection-agent for the specified residence time so that the products/product components are sufficiently covered. Make sure that the
products/product components do not touch each other in the process and activate the ultrasound (do not use any heating function) for
the specified residence time (but not less than 5 min).
2. After switching off the ultrasound, support cleaning in a separate cleaning bath by completely brushing off all internal and external
surfaces with a soft brush. (For recommendations on the brush type, see `Special instructions´ in the attachment)
3. Then remove the products/product components from the cleaning bath and rinse or flush these thoroughly with DI water at least three
times (for at least 1 minute each) (The bacterial load must correspond at least to that of drinking water with a maximum of 100 CFU and
with a low endotoxin load at the same time).
4. Inspect the products/product components (see the chapters `Inspection´ and `Maintenance´).
Disinfection
5. Place the dismantled, cleaned and inspected products/product components in the ultrasonic bath in a fresh cleaning/disinfectant solution
for the specified residence time so that the products/product components are sufficiently covered. Make sure that the products/product
components do not touch each other in the process.
6. Then remove the products/product components from the disinfection bath and rinse or flush these thoroughly with DI water at least five
times (for at least 1 minute each) (The bacterial load must correspond at least to that of drinking water with a maximum of 100 CFU and
with a low endotoxin load at the same time).
7. Dry the products/product components by blowing off/blowing out with sterile filtered compressed air.
8. Pack the products/product components as soon as possible after drying (see the chapter `Packaging´, if necessary after additional drying
in a clean place).
An independent accredited and recognised (§ 15 (5) MPG) test laboratory (Medical Device Services – DR: ROSSBERGER GmbH, Gilching)
has provided proof of the general suitability of the products/product components for effective manual cleaning and disinfection by using the
combined cleaning/disinfection agent ID 213 (DÜRR Dental, Bietigheim-Bissingen) for both the cleaning and disinfection steps. The method
described above was considered and the combined cleaning/disinfection agent ID 213 (DÜRR Dental, Bietigheim-Bissingen) with a
concentration of 2% was used for preliminary cleaning. The Sonorex Super RK 514 H from Bandelin was used as the ultrasonic device.
value > 3000 or – for older devices – at least 5 min at 90°C/194°F) is used wherever
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