FAQ - Frequently Asked Question

HEINE Mango Standard F.O. 4 LED NT


General


Cómo puedo cambiar la fuente de luz de mi HEINE Mango de laryngoscopio?

Los LEDs HEINE presentarán una duración extremadamente larga sosteniendo su calidad de iluminación durante toda la vida útil del producto. Por lo tanto, un cambio del LED no es necesario.


Reprocesamiento higiénico


How can I do the spaulding classification?

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulation and Guidance/GuidanceDocuments/UCM253010.pdf; pages 11,12


Which Brush shall I use for which surface?

• For the easy to access surfaces, use a large brush
• For the difficult to access places brush them at least 5 times using a small, round plastic brush. 


What do I need aditionally for manual disinfection?

• Clean disinfection container or sink / Size: at least 30 x 30 x 10 cm
• sterile, dry cloth
• Sterile demineralized water


What must I consider in terms of manual disinfection?

Avoid air pockets.


What must I consider in terms of automated cleaning and disinfection?

• The washer/disinfector must be loaded so as not to interfere with the result of the cleaning procedure.
• Rinsing processes must guarantee that all areas are sufficiently free of residue.


Which A0-Value must be reached? (ISO 15883-1)


For which Laryngoscope Handles can I use VHP® Sterilization (Steris)?

VHP® Sterilization (Steris) is approved for the STANDARD XHL or LED handles with NiMH battery or dry cell batteries.


For which Laryngoscope Handles can I use hydrogen peroxide gas palasma sterilization (STERRAD ®)?

Hydrogen peroxide gas palasma sterilization (STERRAD ®) is only approved for STANDARD dry cell battery handle.

Only bottom inserts for the STANDARD battery handle produced after 12.2017, can be sterilized using a STERRAD®-procedure.


Which brushes do I need for manual cleaning?

Soft plastic brushes:
•  Large brush; length: at least 10 cm
•  small, round plastic brush:
Brush diameter: 1 cm; 
Brush length: at least 1.5 cm 
• Round plastic brush: Brush diameter suitable for the inner lumen of the handle shell ;
Brush length: at least 10 cm 


How shall I clean the mobile ring in the laryngoscope head?

Push the mobile ring from the inside outwards with a round plastic brush and brush the area around the ring and the blade snap-in mechanism 5 times with a small, round plastic brush. Brush the interior of the flexible ring 3 times with the small brush. 


How often shall I brush for manual cleaning?

Brush at least 3 times (submerged in the cleaning solution)


What do I need aditionally for manual cleaning?

• Clean, dry cloth 
• Clean container or sink ; Size: at least 30 x 30 x 10 cm 
• Demineralized water
• Soft plastic brushes


Can I use flash autoclaving?

Flash autoclaving is not permitted.


When can I charge the handle and when shall I reprocess it?

Perform reprocessing before and after changing the battery


Which water quality do I need for hygienic reprocessing?

Demineralized water.
Sterile water for rinsing after disinfection.


How can I do the spaulding classification in Germany according to KRINKO/RKI?

https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medprod_Rili_2012.pdf?__blob=publicationFile


I need help for choosing the right reprocessing procedure.

Please use the decision tree for choosing the reprocessing procedure.


Where can I find lists of EPA-registered disinfectants?

https://www.epa.gov/pesticide-registration/selected-epa-registereddisinfectants


What is the reason for the necessity for EPA-registered claim for activity against Mycobacterium tuberculosis and Hepatitis B?

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf; pages 11,12


Can I do high level disinfection or sterilization using wipe disinfection?

Wiping does not achieve high-level disinfection or sterilization.


How shall I load the handle shells in the washer disinfector?

Place the handle shells in the washer/disinfector with their large opening pointing downwards, in a tilt-resistant manner and without touching each other. 


Una pregunta rápida. Gran ayuda.

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