Processing Instructions For Thermolabile Products; General Principles; Pre-Treatment; Manual Cleaning And Disinfection - Coltene CanalPro Jeni Manual De Instrucciones

CanalPro Jeni

2. Processing instructions for thermolabile products

2.1.

General principles

All products/product components must be cleaned and disinfected before each application; this also applies in particular to the first use after
delivery, as all products/product components are delivered non-sterile (cleaning and disinfection after removal of the protective transport
packaging). Effective cleaning and disinfection are indispensable prerequisites for safe use.
As part of your responsibility for the safety of the products/product components during application, please note that only sufficient product-
specific validated methods for cleaning and disinfection are used and that the validated parameters are adhered to for each cycle.
Material resistance:
When selecting disinfectants, please make sure that the following components are not included:
- Acids or alkalis (disinfectants for residue-free surface disinfection on an alcoholic basis are recommended)
- other organic solvents (e.g. aldehydes, acetone, ethers, benzines)
- Oxidising agents (e.g. hydrogen peroxides)
- Halogens (chlorine, iodine, bromine)
- aromatic/halogenated hydrocarbons
- Oils (including instrument oils)
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 60°C (140°F)!
Please also observe the legal regulations valid in your country and the hygiene regulations of your medical practice or hospital.
Additional or deviating specifications apply to some products/product components (see the chapter `Special instructions´).
2.2.

Pre-treatment

Immediately after the application (within a maximum of 2 h) all visible residuals must be removed from the products/product components
and the products/product components must be disinfected:
Procedure:
Pre-treatment
1. Separate components that require separate cleaning, disinfection and sterilisation according to the specific processing instructions (see
`Special instructions´ in the attachment).
2.3.

Manual cleaning and disinfection

Selecting the disinfectant
Care must be taken when selecting the disinfectant to ensure
- that these are suitable for the residue-free disinfection of medical surfaces made of metals and plastics in principle (alcoholic basis,
without fragrances and perfumes),
- that these have a tested effectiveness (e.g. VAH/DGHM listing or CE marking)
- that the chemicals used are compatible with the products/product components (see the chapter `Material resistance´ in section 2.1.).
The concentrations, temperatures and residence times specified by the manufacturer of the disinfectant must be adhered in any case. Only
use a fresh solution and a soft, clean and lint-free disposable cloth for drying.
Procedure:
Cleaning
1. Remove the remaining products/product components from all accessible places in the relevant areas (see the chapter `Special
instructions´ in the attachment) with a disposable wipe soaked in at least 50 ml of disinfectant.
2. Repeat step 1 until the surface appears free of visible residues.
3. Inspect the products/product components (see the chapters `Inspection´ and `Maintenance´).
Disinfection
4. Wet the products/product components on all accessible places in the relevant areas (see the chapter `Special instructions´ in the
attachment) with a disposable wipe soaked in at least 50 ml of disinfectant and allow the disinfectant to have an effect according to the
residence time specified by the manufacturer of the disinfectant (but not less than 5 minutes, moisten again if it dries too quickly).
5. Repeat step 4.
6. Allow the surface to completely dry.
An independent officially 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 pre-treatment/manual cleaning and
disinfection by using the disinfectant Bacillol AF (Paul Hartmann AG, Heidenheim). The method described above was considered here.
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