Processing Instructions For Thermostable Products; General Information; Pre-Treatment - Coltene CanalPro Jeni Manual De Instrucciones

CanalPro Jeni

1. Processing instructions for thermostable products

1.1.

General Information

Read the processing instructions carefully and completely. Follow the instructions section by section.
All products/product components must be cleaned, disinfected and sterilised before each application; this applies in particular to the first use
after delivery, since all products/product components are delivered non-sterile (cleaning and disinfection take place after removal of the
protective transport packaging; sterilisation after repackaging). Effective cleaning and disinfection are indispensable prerequisites for
effective sterilisation.
As part of your responsibility for the sterility of the products/product components during application, please note that
- only sufficiently device-specific and product-specific validated methods are used for cleaning, disinfection and sterilisation,
- the equipment used (RDG `cleaning and disinfection device´ and sterilizer) is regularly maintained and correctly checked and
- the validated parameters are adhered to during each cycle.
Material resistance:
When selecting cleaning agents and disinfectants, please make sure that the following components are not included:
- organic, mineral and oxidising acids (minimum permissible pH value 5.5)
- strong alkalis (maximum permissible pH value 12, slightly alkaline cleaner recommended)
- organic solvents (e.g. alcohols, ethers, ketones, benzines)
- Oxidising agents (e.g. hydrogen peroxides)
- Halogens (chlorine, iodine, bromine)
- aromatic/halogenated hydrocarbons
Always refrain from cleaning products/product components with metal brushes or steel wool.
All products/product components may only be exposed to temperatures not exceeding 138°C (280°F)!
If possible, an automated method (RDG (cleaning and disinfection device)) should be used for cleaning and disinfection. Due to its
significantly lower effectiveness and reproducibility, a manual method, even when using an ultrasonic bath, should only be used if an
automated method is not available.
Pre-treatment must be carried out in both cases.
Please also observe the legal regulations valid in your country and the hygiene regulations of your medical practice or hospital. This applies
in particular to the different specifications regarding effective prion inactivation.
Additional or deviating specifications apply to some products/product components (see chapter `Special instructions´ in the attachment).
1.2.

Pre-treatment

Immediately after the application (within a maximum of 2 h) all visible residuals must be removed from the products/product components:
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´, 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:
1. Remove externally visible dirt with a disposable cloth dipped in the cleaning and disinfection bath.
2. Dismantle the products/product components as far as possible (see also the chapter `Special instructions´.
3. Place the products/product components in the cleaning/disinfection solution in the ultrasonic bath (temperature <35°C/95°F) and activate
the ultrasound for the specified residence time (but not less than 5 min).
4. After switching off the ultrasound, manually remove all visible dirt in a separate cleaning bath. Use a clean soft brush (1 minute brushing)
that you only use for this purpose; never use metal brushes or steel wool. (For recommendations on the brush type, see `Special
instructions´ in the attachment)
5. Rinse or flush thoroughly with DI water for at least 1 minute (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).
Now continue to section 1.3. If an automated method is not available continue to 1.4
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