Intended Use - Miele PG 8582 Operating Instructions Manual

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 and
(thermally or chemo-thermally) disinfect 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.
Anaesthetic and intensive care instruments as well as baby bottles
and teats must be allowed to dry thoroughly after reprocessing.
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
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
0
depending on the disinfection result required. The efficacy standard
A 3000 is suitable for deactivating the HBV virus.
0
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.
concept described in EN ISO 15883-1, thermal
3000),
0