Intended use
8
This Miele washer-disinfector is a Class IIb medical device (Directive
93/42/EEC).
This Miele washer-disinfector can be used to clean, rinse, disinfect
and dry reprocessable medical devices in healthcare institutions,
such as surgeries, hospitals and outpatient clinics. It is also essential
to heed the information issued by the manufacturers of the medical
devices (EN/ISO 17664), as well as the information issued by the
process chemical manufacturers.
Examples of application areas:
- surgical instruments including those used in minimally invasive
surgery (MIC),
- anaesthetics and intensive care,
- ophthalmology,
- arthroscopy and rectoscopy, with the exception of flexible
endoscopes,
- ear, nose and throat surgery,
- gynaecology and urology,
- baby bottles and teats,
- ward end utensils such as kidney dishes, bowls and theatre shoes,
- hospital laboratories.
Processing items by machine achieves reproducible results and
should be used in preference to processing them by hand. Where
disinfection is required for the protection of staff and/or patients, a
thermal disinfection programme, e.g. the Vario TD programme should
be selected.
- Heat-sensitive theatre shoes are an exception to this. They should
be reprocessed using a chemo-thermal disinfection programme.
According to the A
0
concept described in EN ISO 15883-1, thermal
disinfection occurs at 80°C (+ 5 °C, - 0 °C) with 10 min holding time
(A
0
600), or at 90°C (+ 5 °C, - 0 °C) with 5 min holding time (A
0
3000),
depending on the disinfection result required. The efficacy standard
A
0
3000 is suitable for deactivating the HBV virus.
Regional and/or other official directives may apply (CFPP, HTM or
relevant technical memorandums in the UK). Refer to your country's
local and national health and safety regulations and guidelines.
The cleaning programme must be chosen according to the type of
soiling and load being processed.
The agents used for reprocessing the products should be selected to
suit the level of cleaning required.
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