HEINE EasyClean LED Laryngoscope Handle

Index

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

Wiping does not achieve high-level disinfection or sterilization.

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

Where can I find lists of EPA-registered disinfectants?

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

I need help for choosing the right reprocessing procedure.

Please use the decision tree for choosing the reprocessing procedure.

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

Is a regular wiping disinfection sufficient?

Periodically a reprocessing procedure with a  final sterilization must be performed, as this is the most effective method. We recommend all 10 applications.

Which water quality do I need for hygienic reprocessing?

Demineralized water.
Sterile water for rinsing after disinfection.

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

Perform reprocessing before and after changing the battery

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

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

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.

What must I consider in terms of manual disinfection?

Avoid air pockets.

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

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. 

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

How can I do the spaulding classification?

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

What shall I do to avoid reactions with subsequent treatment stages?

After cleaning, the handle must be rinsed free of residue in order to avoid reactions with subsequent treatment stages/ damage to the materials.

Can I perform hygienic reprocessing without removing the batteries?

If you use reprocessing programs with temperatures below 60°C (Low-Temperature Procedures) or if the battery manufacturer´s instructions allow the temperatures of the used procedures, you can reprocess the handle without removing the batteries. 

For which procedures do I need to remove the batteries?

Procedures using temperatures over 60 C , e.g.: 

- automated cleaning and disinfection in a washer disinfector
- autoclave/steam sterilization

For which procedures can I leave the batteries in the handle?

Procedures using tempperatures under 60°C , e.g.:
- manual cleaning and disinfection  
- low temperature sterilization (VHP/STERRAD)

Can I combine automated cleaning and disinfection with STERRAD/VHP(Steris)?

Yes you can, but you need to remove the batteries before automated cleaning and disinfection.

Can I combine manual cleaning and disinfection with steam sterilization?

Yes you can, but you need to remove the batteries before steam sterilization.

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  

Can I use flash autoclaving?

Flash autoclaving is not permitted.