Intended Use - Miele PG8582 CD Operating Instructions Manual

Intended use

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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
(thermally and chemo-thermally) and dry reusable medical devices
such as those use in surgeries, hospitals and outpatient clinics.
Follow the manufacturer's instructions (according to EN ISO 17664)
and local and national requirements and guidelines, on how to
process their items by machine as well as instructions provided by
the manufacturer of any chemical agents used.
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.
Medical devices for reprocessing are referred to as the wash load if
they are not more closely defined.
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
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disinfection occurs at 80°C (+ 5 °C, - 0 °C) with 10 min holding time
(A 600), or at 90°C (+ 5 °C, - 0 °C) with 5 min holding time (A
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depending on the disinfection result required. The efficacy standard
A 3000 is suitable for deactivating the HBV virus.
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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.
concept described in EN ISO 15883-1, thermal
3000),
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