FAQ - Frequently Asked Question

HEINE EasyClean LED Laryngoscope Handle

• Hygienic Reprocessing

Hygienic Reprocessing

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

Wiping does not achieve high-level disinfection or sterilization.

Where can I find lists of EPA-registered disinfectants?

https://www.epa.gov/pesticides

How can I do the spaulding classification?

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

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

How often shall I brush for manual cleaning?

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

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 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)

The A0-Value must be at least 3000 (ISO 15883-1)

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