neodisher® MediClean forte

Detergent for reprocessing thermostable and thermolabile instruments Liquid concentrate

neodisher® MediClean forte Fields of application:

Automated cleaning of thermostable and thermolabile instruments including MIS instruments and micro-instruments, flexible endoscopes, anaesthesia equipment, containers and other medical utensils
Also suitable for the manual and automated cleaning of da Vinci-EndoWrist instruments
Manual cleaning of thermostable and thermolabile instruments in immersion baths or ultrasonic baths
Automated and manual cleaning of personal protective equipment

Performance spectrum:

Reliably removes residues of dried and denatured blood
Fulfils the current recommendations of the German Robert-Koch-Institute (RKI) for minimising the transmission risk of the new variant of the Creutzfeldt-Jakob Disease (vCJD) when reprocessing medical devices
Supports the removal of biofilms
Anodised aluminium must be tested first for suitability

Greatly reduces the amount of organic material and prevents the re-deposition of protein residues
Removes pathogenic prion proteins of different prion test strains; amongst those the vCJD test strain by > 2 lg steps (1 %, 55 °C, 10 min)²
Suitable for instruments and utensils made of stainless steel, instrument steel, optics, conventional plastics and the materials of anaesthesia equipment

Special properties:

Excellent material compatibility
When used for manual pre-cleaning the cleaner solution does not have to be rinsed off prior to reprocessing
No hazard label; non-hazardous product
First-class cleaning activity due to the singular formula based on alkalinity donors, surfactants and enzymes
No neutralising step necessary for automated reprocessing; therefore short program cycles

Application and dosage:

neodisher® MediClean forte can be used in washer disinfectors as well as in dip and ultrasonic baths. The dosing amount depends on the respective field of application and the individual degree of contamination of the instruments to be reprocessed. When reprocessing da Vinci EndoWrist instruments neodisher® MediClean forte can be used in all manual pre-cleaning steps, for ultrasonic pre-treatment and for the automated reprocessing process.

Personal protective equipment cleaned in an immersion bath must be completely wet with the application solution during the entire immersion time. Then rinse thoroughly under running water of at least drinking water quality.

The following parameters are recommended when using neodisher® MediClean forte:

Automated and manual cleaning of instruments:

Special properties:

Excellent material compatibility
When used for manual pre-cleaning the cleaner solution does not have to be rinsed off prior to automated reprocessing
No hazard label; non- product
First-class cleaning activity due to the singular formula based on alkalinity donors, surfactants and enzymes
No neutralising step necessary for automated reprocessing; therefore short program cycles

Application and dosage:

neodisher® MediClean forte can be used in washer disinfectors as well as in dip and ultrasonic baths. The dosing amount depends on the respective field of application and the individual degree of contamination of the instruments to be reprocessed. When reprocessing da Vinci EndoWrist instruments neodisher® MediClean forte can be used in all manual pre-cleaning steps, for ultrasonic pre-treatment and for the automated reprocessing process.

Personal protective equipment cleaned in an immersion bath must be completely wet with the application solution during the entire immersion time. Then rinse thoroughly under running water of at least drinking water quality.

The following parameters are recommended when using neodisher® MediClean forte:

Automated and manual cleaning of instruments:

Automated cleaning of thermostable and thermolabile instruments Standard dosage	*2 – 10 ml/l (0.2 – 1.0 %), e.g. 40 – 60 °C, 10 min5 ml/l (0.5 %),* e.g. 55 °C, 10 min
Automated cleaning of flexible endoscopes and endoscopic accessories	5 ml/l (0.5 %), 35 – 55 °C, 5 min
Automated cleaning of da Vinci EndoWrist instruments	8 ml/l (0.8 %), 40 – 55 °C, 10 – 30 min**
Manual cleaning of thermostable and thermolabile instruments in dip and ultrasonic baths	*5 – 20 ml/l (0.5 – 2 %), max. 40 °C, 10 – 30 min**
Manual cleaning of flexible endoscopes as well as endoscopic accessories in dip and ultrasonic baths	*5 – 30 ml/l (0.5 – 3 %), max. 40 °C, 5 – 10 min**
Manual cleaning of da Vinci EndoWrist instruments in dip and ultrasonic baths	10 ml/l (1.0 %), max. 40 °C

Automated and manual cleaning of personal protective equipment

Manual cleaning of breathing apparatuses/respirators and their accessories in immersion baths	*10 ml/l – 30 ml/l (1.0 % – 3.0 %), cold water up to max. 40 °C, 15 – 30 min.**
Automated cleaning of specific personal protective equipment (clearance in accordance with manufacturer’s information), breathing apparatuses/respirators and their accessories in washerdisinfectors and/or washer extractors (program specifications in accordance with manufacturer’s information)	10 ml/l (1 %), 55°C, 2 min

* the dosing amount depends on the degree of soiling
** depending on the respective recommendation of the washer-disinfector manufacturer

Use suitable dosing devices

In the cleaning step and in the final rinse the use of deionised water is recommended. The neutralisation step which is obligatory when using classical alkaline detergents is not necessary. When reprocessing ophthalmological
instruments an additional intermediate rinse with water prior to the final rinse is recommended. The working solution for manual cleaning is to be renewed daily and in the case of visible soiling.

Healthcare Solutions - Babich Maintenance & Steriliser Services

Notes on application:

For professional use only
Rinse out dosing system including suction hose with water before changing product
Reprocessing should comply with all ordinances pursuant to the Medical Device Directive and should be performed with appropriate validated processes
The neodisher® MediClean forte working solution has to be rinsed off completely (preferably with de-ionised water)

To prevent water stains we recommend using de-ionised water in the final rinse/ when rinsing
Do not mix with other products
Please observe the medical device manufacturer´s recommendations for use according to the requirements of DIN EN ISO 17664 as well as the recommendations of the PPE manufacturer
The instructions given by the manufacturer of the washer disinfector are to be observed

Expert reports:

The process reports for reprocessing da Vinci instruments can be obtained on request.
neodisher®MediClean forte has been applied and positively assessed by the different testing and approval bodies in the framework of PPE approvals.

Expert reports:

The process reports for reprocessing da Vinci instruments can be obtained on request.
neodisher®MediClean forte has been applied and positively assessed by the different testing and approval bodies in the framework of PPE approvals.

Technical data:

pH-range	Approx. 10.4 – 10.8 (2 – 10 ml/l, determined in deionised water, 20 °C), in mains water or softened water as well as with carried-over pre-rinsing water, the pH-value can be different
Density	Approx. 1.1 g/cm3 (20 °C)
Viscosity	< 10 mPa s (concentrate, 20 °C)
Titration factor	0.77 (according to the neodisher® MediClean forte titration instructions)

Ingredients:

Ingredients according to Regulation (EC) No 648/2004 on detergents: < 5 % non-ionic and anionic surfactants also: enzymes

CE-mark:

neodisher® MediClean forte complies with European guidelines for medical devices. If a serious incident occurs with the product, report it to the manufacturer and the relevant national authority.

Storage information:

Store in a cool but frost-free place. Always store at a temperature between 0 °C and 25 °C. Do not expose to sunlight. Usable for 2 years when stored as recommended. For expiry date refer to the stamp mark on the label behind the hourglass symbol.

Changes in the colour of the product may occur when storing in factory-sealed trade units. This has no impact on the properties of the product which are relevant for application.

Hazard and precautionary statements:

neodisher® MediClean forte is not a hazardous product according to the CLP-Regulation (EC) No 1272/2008.
Dispose only when container is empty and closed. For disposal of product residues, refer to Safety Data Sheet.
For further safety information see EC Safety Data Sheets. These are available at www.drweigert.com under the headline “Service/Downloads”.