HEINE Standard F.O. 4 LED NT Laryngoscope Handle

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)

The A0-Value must be at least 3000 (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 do high level disinfection or sterilization using wipe disinfection?

Wiping does not achieve high-level disinfection or sterilization.

How do I change the light source in my HEINE LED Laryngoscope Handle?

HEINE LED Laryngoscope Handle: The HEINE LEDs feature an extremely long durability, sustaining their illumination quality throughout the whole product life time. Therefore an exchange of the LED is not necessary.

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.

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.

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

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.